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The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1455 - 1462
1 Nov 2016
Matharu GS Berryman F Brash L Pynsent PB Dunlop DJ Treacy RBC

Aims. We investigated whether blood metal ion levels could effectively identify patients with bilateral Birmingham Hip Resurfacing (BHR) implants who have adverse reactions to metal debris (ARMD). Patients and Methods. Metal ion levels in whole blood were measured in 185 patients with bilateral BHRs. Patients were divided into those with ARMD who either had undergone a revision for ARMD or had ARMD on imaging (n = 30), and those without ARMD (n = 155). Receiver operating characteristic analysis was used to determine the optimal thresholds of blood metal ion levels for identifying patients with ARMD. Results. The maximum level of cobalt or chromium ions in the blood was the parameter which produced the highest area under the curve (91.0%). The optimal threshold for distinguishing between patients with and without ARMD was 5.5 µg/l (83.3% sensitivity, 88.4% specificity, 58.1% positive and 96.5% negative predictive values). Similar results were obtained in a subgroup of 111 patients who all underwent cross-sectional imaging. Between 3.2% and 4.3% of patients with ARMD were missed if United Kingdom (7 µg/l) and United States (10 µg/l) authority thresholds were used respectively, compared with 2.7% if our implant specific threshold was used, though these differences did not reach statistical significance (p ≥ 0.248). Conclusion. Patients with bilateral BHRs who have blood metal ion levels below our implant specific threshold were at low-risk of having ARMD. Cite this article: Bone Joint J 2016;98-B:1455–62


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 107 - 107
1 Mar 2017
Reiner T Bader N Panzram B Kretzer J Zeifang F
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Purpose. Total shoulder arthroplasty (TSA) has become a successful treatment option for degenerative shoulder disease. With the increasing incidence in primary TSA procedures during the last decades, strategies to improve implant longevity become more relevant. Implant failure is mainly associated with mechanical or biological causes. Chronic inflammation as a response to wear particle exposure is regarded as a main biological mechanism leading to implant failure. Metal ions released by fretting and corrosion at modular taper connections of orthopedic implants can cause cell-mediated hypersensitivity reactions and might lead to aseptic loosening. Modularity is also commonly used in total shoulder replacement. However, little is known about metal ion exposure in patients following TSA. The objective of this study was to determine in-vivo blood metal ion levels in patients after TSA and to compare blood metal ion levels to control subjects without metal implants. Methods. A total of 19 patients with anatomical total shoulder prosthesis (TSA group) and 20 patients with reverse total shoulder prosthesis (RSA group) who underwent unilateral total shoulder replacement at our hospital between March 2011 and December 2014 with no other metal implant or history of environmental metal ion exposure were recruited for analysis of blood metal ion concentrations of cobalt (Co), chromium (Cr) and titanium (Ti) at a mean follow-up period of 2.3 years (0.7–4.3). For comparison of metal ion concentrations blood samples were obtained in a healthy control group of 23 subjects without metal implants. Ethical approval and informed consent of each patient were obtained for this study. Results. Median cobalt ion levels were 0.14µg/l (range 0.03–0.48) in the TSA group, 0.18 µg/l (0.10–0.66) in the RSA group and 0.11µg/l (0.03–0.19) in the control goup. Median chromium ion levels were 0.34µg/l (0.09–1.26) in the TSA group, 0.48µg/l (0.17–2.41) in the RSA group and 0.14µg/l (0.04–0.99) in the control goup. Median titanium ion levels were 0.86µg/l (0.10–1.64) in the TSA group, 1.31µg/l (0.75–4.52) in the RSA group and 0.62µg/l (0.32–2.14) in the control goup. There was a statistically significant difference in chromium and titanium ion concentrations between both study groups and the control group (see figure 1–3). Conclusion. Patients with unilateral total shoulder replacement demonstrated elevated blood metal ion concentrations. Median blood metal ion levels were higher in the RSA group compared to the TSA group, which could be attributable to the modularity of the reverse total shoulder system. However, overall metal ion levels were relatively low compared to those seen in patients with metal-on-metal total hip replacements. The role of local metal ion exposure in the development of aseptic loosening or hypersensitivity reactions associated with total shoulder arthroplasty should be further investigated. For figures/tables, please contact authors directly.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 22 - 22
1 Dec 2022
Werle J Kearns S Bourget-Murray J Johnston K
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A concern of metal on metal hip resurfacing arthroplasty is long term exposure to Cobalt (Co) and Chromium (CR) wear debris from the bearing. This study compares whole blood metal ion levels from patients drawn at one-year following Birmingham Hip Resurfacing (BHR) to levels taken at a minimum 10-year follow-up. A retrospective chart review was conducted to identify all patients who underwent a BHR for osteoarthritis with a minimum 10-year follow-up. Whole blood metal ion levels were drawn at final follow-up in June 2019. These results were compared to values from patients with one-year metal ion levels. Of the 211 patients who received a BHR, 71 patients (54 males and 17 females) had long term metal ion levels assessed (mean follow-up 12.7 +/− 1.4 years). The mean Co and Cr levels for patients with unilateral BHRs (43 males and 13 females) were 3.12 ± 6.31 ug/L and 2.62 ± 2.69 ug/L, respectively, and 2.78 ± 1.02 ug/L and 1.83 ± 0.65 ug/L for patients with bilateral BHRs (11 males and 4 females). Thirty-five patients (27 male and 8 female) had metal-ion levels tested at one-year postoperatively. The mean changes in Co and Cr levels were 2.29 ug/l (p = 0.0919) and 0.57 (p = 0.1612), respectively, at one year compared to long-term. These changes were not statistically significant. This study reveals that whole blood metal ion levels do not change significantly when comparing one-year and ten-year Co and Cr levels. These ion levels appear to reach a steady state at one year. Our results also suggest that regular metal-ion testing as per current Medicines and Healthcare products Regulatory Agency (MHRA) guidelines may be impractical for asymptomatic patients. Metal-ion levels, in and of themselves, may in fact possess little utility in determining the risk of failure and should be paired with radiographic and clinical findings to determine the need for revision


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 100 - 100
1 May 2016
Ziaee H Matharu G Daniel J Pynsent P McMinn D
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High short-term failure rates have been observed with a number of metal-on-metal (MoM) hip designs. Most patients require follow-up with blood metal ions, whichprovide a surrogate marker of in-vivo bearing wear. Given these results are used in clinical decision making it is important values obtained within and between laboratories are reproducible. To assess the intra-laboratory and inter-laboratory variability of blood metal ion concentrations analysed by four accredited laboratories. Whole blood was taken from two participants in this prospective study. The study specimen was obtained from a 42 year-old female with ceramic-on-ceramic hip arthroplasty failure resulting in unintended metal-on-ceramic wear and excessively high systemic metal ion levels. The control specimen was from a 52 year-old healthy male with no metal exposure. The two specimens were serially diluted to produce a total of 25 samples with different metal ion concentrations in two different anticoagulants each. Thus 50 samples were sent blinded in duplicate (total 100) to four accredited laboratories (A, B, C, D) to independently analyse blood metal ion concentrations. Ten commercially available reference specimens spiked with different amounts of metal ions were also obtained with known blood metal ion concentrations (range for cobalt 0.15µg/l-11.30µg/l and chromium 0.80µg/l to 37.00µg/l) and analysed by the four laboratories. The intra-laboratory coefficients of variation for repeat analysis of identical patient specimens were 7.32% (laboratory A), 4.64% (B), 7.50% (C), and 20.0% (D). The inter-laboratory variability for the analysis of all 25 samples was substantial. For the unmixed study specimen the laboratory results ranged from a cobalt of 263.7µg/l (D) to 525.1µg/l (D) and a chromium of 13.3µg/l (D) to 36.9µg/l (A). For the unmixed control specimen the laboratory results ranged from a cobalt of 0.13µg/l (B) to 0.77µg/l (D) and a chromium of 0.13µg/l (D) to 7.1µg/l (A). For one of the mixed specimens the laboratory results ranged from a cobalt of 12.50µg/l (A) to 20.47µg/l (D) and a chromium of 0.73µg/l (D) to 5.60µg/l (A). Similar inter-laboratory variation was observed for the other mixed samples. The true mean (standard deviation) of the 10 commercial samples was 4.48µg/l (4.20) for cobalt and 8.97µg/l (10.98) for chromium. This was similar to the values obtained by all four laboratories: mean (standard deviation) cobalt ranged from 3.54µg/l (3.17) in laboratory A to 4.35µg/l (4.13) in laboratory D, and chromium ranged from 7.76µg/l (9.50) in laboratory B to 9.55µg/l (9.16) in laboratory A. When testing patient samples, large variations existed both between and within four laboratories accredited to perform analysis of blood metal ion concentrations. However, this was not the case when assessing commercially spiked samples which are regularly used to validate laboratory testing. This is of great clinical concern and could lead clinicians to either recommend unnecessary revision or delay surgery, with both having the potential to adversely affect patient outcomes. It is recommended that laboratories use patient samples to assess the accuracy and reproducibility of the analyses performed. This may also assist in explaining the variations observed in this study


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_29 | Pages 61 - 61
1 Aug 2013
van der Jagt D Mokete L Nwokeyi K Schepers A
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Metal ion levels are used to track the performance of metal containing bearings in hip replacement patients. Changes in whole blood metal ion levels are indicators of wear rates in these bearings. Normal metal ion levels are variable, and range widely. Changes in these “non-bearing” levels over a period of time may influence the monitoring of these bearings. Methods. As part of a prospective randomised trial of different bearing surfaces, whole blood metal ion levels were monitored. This included four cohorts of patients, namely ceramic-on-ceramic (CoC), ceramic-on-polyethylene (CoP), ceramic-on-ceramic (CoC) and ceramic-on-metal (CoM). Serial whole blood metal ion levels in the non-metal bearings, namely CoC and CoP, were analyzed. Results. There was no consistency in these whole blood metal ion levels. Intra-patient variations in these levels over a period of time could not be due to bearing-produced metal ions as these were all metal free, and thus not the source of any endogenous ions. These intra-patient variations may reflect changes in exogenous exposure to these metal ions, fluctuations in these patient's metabolic functions or production of metal ions from non-bearing prosthetic sources. Conclusion. This finding of variations of “normal” intra-patient whole blood metal ions highlights the importance of determining a patient's average baseline levels, particularly when these are used to determine changes in these levels when part of a protocol to monitor the performance of metal containing hip replacement bearings


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 29 - 29
1 Mar 2012
van der Jagt D Williams S Brekon A Schepers A Isaac G Fisher J
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The search for the ideal bearing surface in Total Hip Replacements continues. The current ‘best’ materials are felt to be combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best bearing surface combination with the lowest adverse side effect profile. Between February 2004 and September 2007, 164 hips were replaced in 142 patients. 39% were male and 69% were female. The average age at surgery was 53 years (17-72 years). Follow-up assessment included radiographs, the Harris Hip Score and whole blood samples for metal ion levels. Complications to date included 3 hips which needed femoral revision because of surgery related factors, and 3 cases of sepsis of which 1 settled and 2 needed revision. One hip needed revision of head and liner to a larger bearing size for recurrent dislocations, and is no longer being followed up for blood metal ions. Post-operative whole blood metal ion levels were compared to pre-operative levels to determine the increase or decrease in metal ion levels. There were no changes in those patients with ceramic-on-ceramic and ceramic-on-polyethylene articulations. Moderately raised whole blood metal ion levels were noted at 3 months in the ceramic-on-metal group, while the metal-on-metal group show the greatest increase. This study agrees with laboratory bearing surface wear studies demonstrating lower wear rates in the ceramic-on-metal group compared to the metal-on-metal group. With concerns related to high blood metal ion levels in metal-on-metal articulations, ceramic-on-metal bearing surfaces may well become a bearing surface of choice in the future, but progress needs to be monitored in the longer term


Bone & Joint Research
Vol. 5, Issue 9 | Pages 379 - 386
1 Sep 2016
Pahuta M Smolders JM van Susante JL Peck J Kim PR Beaule PE

Objectives. Alarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs. Methods. We searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model. Results. Our literature search returned 575 unique articles; only six met inclusion criteria defined a priori. The discriminative capacity of ion tests was homogeneous across studies but that there was substantial cut-point heterogeneity. Our best estimate of the “true” area under curve (AUC) for metal ion testing is 0.615, with a 95% credible interval of 0.480 to 0.735, thus we can state that the probability that metal ion testing is actually clinically useful with an AUC ≥ 0.75 is 1.7%. Conclusion. Metal ion levels are not useful as a screening test for identifying high risk patients because ion testing will either lead to a large burden of false positive patients, or otherwise marginally modify the pre-test probability. With the availability of more accurate non-invasive tests, we did not find any evidence for using blood ion levels to diagnose symptomatic patients. Cite this article: M. Pahuta, J. M. Smolders, J. L. van Susante, J. Peck, P. R. Kim, P. E. Beaule. Blood metal ion levels are not a useful test for adverse reactions to metal debris: a systematic review and meta-analysis. Bone Joint Res 2016;5:379–386. DOI: 10.1302/2046-3758.59.BJR-2016-0027.R1


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 11 - 11
1 Mar 2013
Matthies A Suarez A Karbach L Henckel J Skinner J Noble P Hart A
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There are several component position and design variables that increase the risk of edge loading and high wear in metal-on-metal hip resurfacing (MOM-HR). In this study we combined all of these variables to calculate the ‘contact patch to rim distance’ (CPRD) in patients undergoing revision of their MOM-HR. We then determined whether CPRD was more strongly correlated with component wear and blood metal ion levels, when compared to any other commonly reported clinical variable. This was a retrospective study of 168 consecutively collected MOM-HR retrieval cases. All relevant clinical data was documented, including pre-revision whole blood cobalt and chromium ion levels. Wear of the bearing surfaces was then measured using a roundness-measuring machine. We found four variables to be significantly (p < 0.05) correlated with component wear and blood metal ion levels: (1) cup inclination angle, (2) cup version angle, (3) arc of cover, and (4) CPRD. The correlations between CPRD and both wear and ion levels were significantly stronger than those seen with any other variable (all p < 0.0001). Our study has shown that CPRD is the best predictor of component wear and blood metal ion levels, and may therefore be a useful parameter to help determine those patients who are at risk of high wear and require more frequent clinical surveillance


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 8 - 8
1 Mar 2012
Cobb A Isaac G McLennan-Smith R Oakeshott R Siebel T
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Introduction. A metal ion study was undertaken in patients who had received an articular surface replacement. The design of these components is optimised in line with lubrication theory and produces low levels of wear in hip joint simulators. Methods. Patients were recruited in four centres. Whole blood samples were analysed for metal ion levels using high resolution ICP-MS (inductively coupled plasma mass spectrophotometry). A total of 75 patients was enrolled into the study and 65 and 47 patients were assessed after 12 and 24 months implantation respectively. Results are included irrespective of clinical outcome. Results. The 12 and 24 month median ion levels were 1.4 μg/l and 1.6 μg/l respectively for chromium and 1.5(μg/l and 1.6 μg/l respectively for cobalt. The pre-operative levels were 0.38(μg/l and 0.34(μg/l for chromium and cobalt respectively. Twenty-seven percent of patients had a pre-operative chromium level that was higher than the 24 month median level. Similarly the value for cobalt was seven percent. However close examination of the data shows that it is skewed by 6 outliers with cobalt or chromium levels greater than 10(μg/l after 24 months implantation. This appears to be related to acetabular component placement. Patients with acetabular components implanted at a high inclination angle (>55deg) are more likely to have elevated metal ion levels compared with a standard angle (<55deg). In the 24 month group two patients (both outliers) have been revised. Furthermore, the high metal ion levels at 24 months could be predicted by intermediate levels after 12 months. Conversely those levels below 10ug/l had already stabilised after 12 months in vivo. Conclusion. Large diameter metal-on-metal bearing with optimised tolerances can produce very low blood metal ion levels. However, in line with other studies, mal-positioning of components may lead to significantly elevated levels of wear and hence blood metal ions


Bone & Joint Research
Vol. 2, Issue 5 | Pages 84 - 95
1 May 2013
Sidaginamale RP Joyce TJ Lord JK Jefferson R Blain PG Nargol AVF Langton DJ

Objectives. The aims of this piece of work were to: 1) record the background concentrations of blood chromium (Cr) and cobalt (Co) concentrations in a large group of subjects; 2) to compare blood/serum Cr and Co concentrations with retrieved metal-on-metal (MoM) hip resurfacings; 3) to examine the distribution of Co and Cr in the serum and whole blood of patients with MoM hip arthroplasties; and 4) to further understand the partitioning of metal ions between the serum and whole blood fractions. Methods. A total of 3042 blood samples donated to the local transfusion centre were analysed to record Co and Cr concentrations. Also, 91 hip resurfacing devices from patients who had given pre-revision blood/serum samples for metal ion analysis underwent volumetric wear assessment using a coordinate measuring machine. Linear regression analysis was carried out and receiver operating characteristic curves were constructed to assess the reliability of metal ions to identify abnormally wearing implants. The relationship between serum and whole blood concentrations of Cr and Co in 1048 patients was analysed using Bland-Altman charts. This relationship was further investigated in an in vitro study during which human blood was spiked with trivalent and hexavalent Cr, the serum then separated and the fractions analysed. Results. Only one patient in the transfusion group was found to have a blood Co > 2 µg/l. Blood/Serum Cr and Co concentrations were reliable indicators of abnormal wear. Blood Co appeared to be the most useful clinical test, with a concentration of 4.5 µg/l showing sensitivity and specificity for the detection of abnormal wear of 94% and 95%, respectively. Generated metal ions tended to fill the serum compartment preferentially in vivo and this was replicated in the in vitro study when blood was spiked with trivalent Cr and bivalent Co. Conclusions. Blood/serum metal ion concentrations are reliable indicators of abnormal wear processes. Important differences exist however between elements and the blood fraction under study. Future guidelines must take these differences into account


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 549 - 549
1 Nov 2011
Langton D Jameson S Van Oursouw M De Smet K Nargol A
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Background: Definitive cup position for the reduction of blood metal ion levels has yet to be established. Methods: Samples for serum metal ion analysis are taken routinely from patients under the care of the two senior authors of this paper. Both are high volume experienced hip resurfacing surgeons, one based in England, the other in Belgium. Metal ion results from two centres from patients with unilateral joints were correlated to size and orientation of femoral and acetabular components, UCLA activity score, age, time post surgery and post operative femoral head/neck ratios. EBRA software was used to assess cup inclination and anteversion on standing radiographs. Cup orientation in vivo was compared to explant analysis of 60 retrieved resurfacing components using a coordinate measuring machine. Results: Three resurfacing devices were studied. There were 620 results in total. Only femoral size and cup inclination/anteversion were found to have any effect on ion levels. In all devices, metal ion levels were inversely related to femoral size (p< 0.05). The device providing the smallest acetabular coverage arc was associated with the highest metal ion levels. Consistent throughout the implants, lowest ion levels were associated with cups with radiological inclination of 40–50° and anteversion 10–20°. Cup inclination angles lower than 40° were associated with posterior edge loading and likely sub-luxation of the femoral component. Conclusion: The greater the coverage angle provided by the acetabular component, the greater the tolerance to suboptimal position. Lowest ion levels were found in well positioned lower clearance devices. Cup inclination/ante-version angles of 45/15+/−5° were associated with low ion levels in all three devices. We do not recommend cups to be placed with inclination angles below 40°


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 549 - 549
1 Nov 2011
Langton D Jameson S Joyce T Nargol A
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Background: Blood metal ion levels have been shown to correlate with wear of retrieved components. Increased articular wear is associated with early failure. It is not clear what the management of patients with raised metal ions who remain asymptomatic should be. Methods: A prospective study of the DePuy ASR resurfacing device was commenced in 2004 at our independent centre. Blood and serum metal ion analysis is carried out routinely. We assessed the clinical outcome of all patients with cobalt (Co) concentrations > 5μg/L (n=25). We consider this value to be a clear indicator of a poorly performing bearing surface. Patients who remained asymptomatic were brought back for repeat ions testing and clinical assessment. A parallel study was carried out to examine the relationship between the wear depth of retrieved explants (assessed using a coordinate measuring) and blood ion levels. Results: Increases in chromium(Cr) and Co levels from the second blood sample correlated with the first sample (p< 0.05). The four patients with the highest Cr Co levels went on to suffer spontaneous femoral neck fractures between 3 and 4 years post op (pseudotumours in two of these cases). Of the remaining 25, 5 were revised for worsening pain (large effusions and areas of tissue necrosis were seen at revision) and 10 were under investigation for new onset of pain. Wear depths correlated well with blood ion concentrations (p< 0.05) substantiating the results of another centre. Conclusion: 60% of patients with raised metal ion levels went on to develop complications within two years of the blood test. This suggests patients may only have temporary tolerances to excessive concentrations of metal wear debris. One novel association appears to be spontaneous delayed femoral fracture. Results suggest increased ion concentrations associated with small joint size/sub optimal cup orientation will continue to rise and these patients should be followed up closely


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 131 - 132
1 Mar 2009
van der Jagt D Schepers A
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The search for the ideal bearing surfaces to be used in Total Hip Replacement continues. The current “best” materials are felt to be various combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best combination with the lowest side effect profile. In February 2004 a prospective randomised trial on different bearing surfaces was started. The combinations selected were ceramic-on-cross-linked polyethylene, ceramic-on-ceramic, metal-on-metal and ceramic-on-metal. Institutional ethics clearance was obtained. In all patients uncemented femoral stems are used, with an uncemented porocoated acetabular shell. A uniform 28mm femoral head size was selected. Blood samples have been taken to measure the metal ion concentrations in all patients. These are measured pre operatively, and repeated at follow up visits at 3 months and 1 year, with further follow up at 3,5 and 10 years post operatively. Whole blood ion levels are measured using a graphite furnace atomic absorption spectrometer. Between February 2004 and April 2006 one hundred and ten hips have undergone total hip replacement. There are 105 patients (5 bilateral). 40% are males and 60% female. The average age at operation is 52 years (17 to 72). 49% hips are left and 51% right. Follow up includes blood samples and the Harris Hip Score. Complications to date have been surgeon related, with three femoral components needing early revision for technical reasons. This has not affected the bearing surfaces. Radiological and clinical assessment shows no difference between the different bearing surface groups. Post operative whole blood metal ion levels are compared to the patient’s pre operative level. To date there is no increase in the metal ion levels for the ceramic-on-cross linked polyethylene and ceramic-on-ceramic articulations. The ceramic-on-metal group is providing moderately raised metal ion levels, and the highest metal ion levels are in the metal-on-metal articulation group. At one year, the ceramic-on-metal group demonstrates a drop to close to pre-operative levels and these are still significantly lower than the metal-on-metal group. This confirms laboratory studies on the ceramic-on-metal articulation, which demonstrate significantly lower wear than comparable metal-on-metal articulations. The high level of metal ions in the latter groups has always been of concern. This study demonstrates a lower blood level of metal ions in the ceramic-on-metal group. If the in vivo wear rate in this group continues to replicate the laboratory wear studies, this articulation becomes a very attractive bearing surface in younger active patients, and may well become a bearing surface of choice in the future


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1287 - 1295
1 Oct 2009
Langton DJ Sprowson AP Joyce TJ Reed M Carluke I Partington P Nargol AVF

There have been no large comparative studies of the blood levels of metal ions after implantation of commercially available hip resurfacing devices which have taken into account the effects of femoral size and inclination and anteversion of the acetabular component. We present the results in 90 patients with unilateral articular surface replacement (ASR) hip resurfacings (mean time to blood sampling 26 months) and 70 patients with unilateral Birmingham Hip Resurfacing (BHR) implants (mean time 47 months).

The whole blood and serum chromium (Cr) and cobalt (Co) concentrations were inversely related to the size of the femoral component in both groups (p < 0.05). Cr and Co were more strongly influenced by the position of the acetabular component in the case of the ASR, with an increase in metal ions observed at inclinations > 45° and anteversion angles of < 10° and > 20°. These levels were only increased in the BHR group when the acetabular component was implanted with an inclination > 55°.

A significant relationship was identified between the anteversion of the BHR acetabular component and the levels of Cr and Co (p < 0.05 for Co), with an increase observed at anteversion angles < 10° and > 20°. The median whole blood and serum Cr concentrations of the male ASR patients were significantly lower than those of the BHR men (p < 0.001). This indicates that reduced diametral clearance may equate to a reduction in metal ion concentrations in larger joints with satisfactory orientation of the acetabular component.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 75 - 75
1 Mar 2006
Pattyn C van Overschelde P de Smet K Verdonk R
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Introduction: The purpose of this retrospective study is to compare long-term whole blood metal ion concentrations (Co, Cr, Ni, Mo) between two different metal-on-metal total hip arthroplasties and a metal-on-polyethylene control group, in relationship with physical activity. Materials and methods: Between 1996 and 2000, different conventional prosthetic designs were implanted at our hospital. For this study, three groups were chosen according to the bearing surfaces used. Patients who had undergone other surgical interventions with implantation of potential sources of Cr/Co were excluded. Patients taking medication or dietary supplements containing Cr/Co were also excluded. In group 1, 17 patients with a 28 mm metal-on-metal bearing, type Metasul (Zimmer), were included. Group 2 comprised 11 patients with a 28 mm metal-on-metal bearing, type M2a (Biomet). The control group consisted of 9 patients with a 28 mm metal-on-polyethylene bearing in combination with a cemented CoCr stem. The three groups were demographically comparable. The postoperative clinical performance was evaluated using the Harris hip score and the Merle-dAubigne score. The activity level was measured using the Baecke questionnaire. Whole blood samples were taken in a standardized way and analysed by high resolution inductively coupled plasma mass spectrometer analysis. Results: At an average follow-up of 4 years, the mean Harris Hip Score was 88.35 in group 1, 82.64 in group 2 and 90.89 in the control group. The mean Baecke Activity Score was 7.32 in group 1, 5.51 in group 2 and 6.49 in the control group. The mean Cr level was 0.27 in group 1, 0.63 in group 2 and 0.19 in the control group. The mean Co level was 0.63 in group 1, 1.06 in group 2 and 0.51 in the control group. The mean Ni level was 1.11 in group 1, 1.10 in group 2 and 1.31 in the control group. The mean Mo level was 0.65 in group 1, 0.77 in group 2 and 0.56 in the control group. Conclusions: At a minimum follow-up of 4 years, no statistically significant differences were seen in clinical outcomes among the three groups. The only statistically significant difference in metal ion concentration among the three groups was observed for the Cr concentration between the M2a group and the metal-on-polyethylene group. There is also a positive correlation between the ion concentrations (Cr and Co) on the one hand and the activity level and Body Mass Index on the other


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 156 - 156
1 Mar 2013
Ziaee H Pradhan C Daniel J McMinn D
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Introduction

Metal-metal surface replacement (MoMSRA) continues to be used in young women. Systemic metal ion release and its effects cause concern. Do metal ions crossing the placenta in pregnant women have potential mutagenic effects? The hypothesis is that metal ions pass freely through the placenta and there is no difference in maternal and cord metal levels.

Methods

This is a controlled cross-sectional study of women with MoMSRA. (n = 25, 3 bilateral, mean age 32 years, time from implantation to delivery 60 months). The control group consisted of 24 subjects, mean age 31 years, with no metallic implant and not receiving cobalt/chromium supplements. No patient was known to have renal failure. Whole blood specimens were obtained before delivery and before any infusion or transfusion, and cord blood specimens immediately after delivery.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 520 - 520
1 Oct 2010
Isaac G Breckon A Brockett C Fisher J Schepers A Van Der Jagt D Williams S
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The combination of a ceramic head articulating against a metal acetabular liner (CoM) has shown reduced metal ion levels compared with a metal-on-metal bearing (MoM) in hip simulator studies. A randomized prospective clinical trial was undertaken using CoM and MoM bearings in an otherwise identical total hip procedure. The initial clinical results were encouraging. This report comprises a further review of metal ion data.

Patients received identical components with the exception of the bearing surface material but all were 28mm diameter. All components were supplied by DePuy International Ltd. Patients were assessed pre-operatively, 3m, 12m and > 24m (median 32m). Whole blood samples were collected at regular follow-ups, frozen and analysed in batches using high resolution Inductively Coupled Plasma – Mass Spectrometry (ICP-MS). All recruited patients are included irrespective of outcome. However some patients failed to attend specific follow-ups and some contaminated samples had to be discarded. Statistical significance was analyzed using a non-parametric comparison (Mann-Whitney test). After 3m and 12m implantation there were between 21 and 24 patients available for analysis in both the CoM and MoM cohort and after > 24m point 10 and 9 respectively.

There were four outliers (either Cr or Co > 10ug/l) in both the CoM and MoM groups. In common with previous studies (with the exception of two marginal outliers), these were related to component position. They were implanted with either a cup abduction angle of > 55°, an anteversion angle of > 30° or both. Other studies with the same design of component have reported no significant outliers.

The median Cr and the Co levels are lower with the CoM bearing compared with the MoM at all measurements points following implantation. The median background (pre-operative) levels for the combined CoM and MoM group were Cr: 0.22ug/l and Co: 0.49ug/l. These were significantly different (p=0.006).

In the CoM group, the median 12m Cr and Co values were 0.43ug/l and 0.72ug/l respectively. The comparable values for MoM are 0.68ug/l and 0.83ug/l. Increases in metal ion levels from pre-operative levels are used as the primary ion level outcome in this study because the background level will comprise of the order of 30–50% of the overall value. The increase in Cr for CoM and MoM from pre-op levels to 12m significantly different for Cr (p=0.015). It has a lower significance for combined metal ion levels (p=0.029). This difference in not significant for Co (p=0.195).

In agreement with predictions from hip simulator studies, CoM bearings in this study produced lower levels of metal ions than comparable MoM bearings at all time points. However the difference is less than that predicted in the laboratory and is much more pronounced with Cr than with Co.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_9 | Pages 23 - 23
1 Feb 2013
Parry M Bhabra G Sood A Figgitt M Case P Blom A
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Orthopaedic cobalt chromium particles and ions can induce indirect DNA damage and chromosome aberrations in human cells on the other side of a cellular barrier in tissue culture. This occurs by intercellular signalling across the barrier. We now show that the threshold for this effect depends on the metal form and the particle composition.

Ionic cobalt and chromium induced single strand breaks at concentrations equivalent to those found in the blood of patients with well functioning metal on metal hip prostheses. However, they only caused double strand breaks if the chromium was present as chromium (VI), and did not induce chromosome aberrations. Nanoparticles of cobalt chromium alloy caused DNA double strand breaks and chromosome aberrations, of which the majority were tetraploidy. Ceramic nanoparticles induced only single strand breaks and/or alkaline labile sites when indirectly exposed to human fibroblasts.

The assessment of reproductive risk from maternal exposure to biomaterials, especially those liberated by orthopaedic implants, is not yet possible with epidemiology. Whilst the barrier model used here differs from the in vivo situation in several respects, it may be useful as a framework to evaluate biomaterial induced damage across physiological barriers.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 546 - 546
1 Nov 2011
McArthur J Costa M Griffin D Krikler S Parsons N Pereira G Prakash U Rai S Foguet P
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Introduction: Pain and mass lesions around hip resurfacing are reported with increasing frequency. The aetiology is unknown but reaction to metal wear debris and mechanical impingement have both been suggested. We are aware of a group of our patients with significant pain following resurfacing. We sought to correlate metal ion levels with X-ray findings and any local soft tissue reaction around the prosthesis.

Methods: Patients with significant groin pain following hip resurfacing were identified from routine clinics. Blood was tested for cobalt and chromium levels using inductively coupled mass spectrometry in all patients. Cup abduction angle and femoral stem version were estimated from plain radiographs. Patients underwent ultrasound scan (USS) of the affected hip joint. Bilateral prostheses were excluded to avoid confounding.

Results: 47 unilateral painful hip resurfacings (24 female) were identified. USS was performed in 42 patients and was abnormal in 25 (15 female). Abnormalities ranged from simple joint effusion with or without synovial thickening, through to cystic masses in the posterior joint and solid masses related to the ileopsoas tendon similar to the appearances previously described in pseudotumours.

A two sample t-test demonstrated cobalt and chromium ion levels were significantly higher in patients with abnormalities on USS (p=0.038, p=0.05 respectively), patients with normal USS were more likely to have a retroverted femoral component (p=0.01).

Discussion: We describe two groups of patients with a painful hip resurfacing: those with raised metal ions and local soft tissue reaction, and those with lower metal ions and no soft tissue reaction. The retroverted stems in the second group could cause an iatrogenic cam-type impingement. Metal ion levels are useful to guide further imaging. Raised levels should prompt investigation for a soft tissue abnormality with either USS or MRI, lower levels suggest investigation should look for mechanical impingement with imaging such as CT.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 29 - 29
1 Jan 2013
Sidaginamale R Langton D Lord J Joyce T Nargol A
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Background

We have previously described the relationship between wear rates of MOM components and soft tissue necrosis. In this study we investigated the link between wear rates, metal ion concentrations and osteolysis.

Methods

All unilateral patients who underwent revision of hip resurfacings at our centre were included. Retrieved components were analysed using a coordinate measuring machine to determine total volumetric material loss and rates of wear. Given the accuracy of the wear calculations (which we have previously published), wear rates were considered “abnormal” if ≥3mm3/yr. ROC curves were constructed to determine a Co concentration which would be clinically useful to detect abnormal wear. During revision, the presence/absence of osteolysis was documented.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 390 - 390
1 Jul 2010
Langton D Sprowson A Jameson S Joyce T Reed M Partington P Carluke I Nargol A
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Background: There are no large comparative metal ion studies of commercially available hip resurfacing devices which have taken into account the effects of femoral size and cup inclination and anteversion.

Patients and methods: Metal ion analysis is carried out routinely at our independent centre. We present the metal ion results of 95 unilateral ASR patients and 70 unilateral BHR patients. For all patients, acetabular cup orientation was assessed using EBRA software. Patients with other metallic implants and those within 12 months of surgery were excluded.

Results: Whole blood/serum chromium (Cr) and cobalt (Co) concentrations were inversely related to femoral component size in both the ASR and BHR group (p< 0.05). Cr and Co levels were only seen to increase in the BHR group when the cup was implanted with an inclination greater than 55°. A significant relationship was identifed between the anteversion of the BHR cup and Cr and Co (p< 0.05 for Co, Spearman Rank correlation), with an increase in ions observed at anteversion angles > 17°. Cr and Co were more strongly influenced by cup position in the case of the ASR, with an increase in metal ions observed at inclinations greater than 45° and anteversion angles of < 10° and > 20°.

Discussion: The increased tolerance of the BHR cup to inclinations between 45–55° is likely due to the larger BHR cup providing greater protection against edge loading. When the cohort was divided by gender, the median Cr concentrations of the male ASR patients were significantly lower than those of the BHR males (p< 0.001). This suggests that in larger components positioned at more satisfactory angles of inclination and anteversion, the lower clearance of the ASR proves more significant than the extra coverage provided by the BHR cup. The BHR appears to be more sensitive to changes in anteversion than inclination.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 31 - 37
1 Mar 2024
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A

Aims

In metal-on-polyethylene (MoP) total hip arthroplasty (THA), large metal femoral heads have been used to increase stability and reduce the risk of dislocation. The increased size of the femoral head can, however, lead to increased taper corrosion, with the release of metal ions and adverse reactions. The aim of this study was to investigate the relationship between the size of the femoral head and the levels of metal ions in the blood in these patients.

Methods

A total of 96 patients were enrolled at two centres and randomized to undergo MoP THA using either a 32 mm metal head or a femoral head of between 36 mm and 44 mm in size, being the largest possible to fit the thinnest available polyethylene insert. The levels of metal ions and patient-reported outcome measures (Oxford Hip Score, University of California, Los Angeles Activity Scale) were recorded at two and five years postoperatively.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 34 - 34
23 Jun 2023
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A
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In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA. 96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups. Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups (p=0.825, p=1.000, p=0.558). At 2 years, 7 (32-mm) versus 4 (36–44-mm) patients had elevated ions. At 5 years, 6 (32-mm) versus 7 (36–44-mm) patients had elevated ions. There was no difference in either OHS (p=0.665) or UCLA (p=0.831) between patients with or without elevated blood metal ions. 5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 10 | Pages 1308 - 1313
1 Oct 2011
Hart AJ Sabah SA Bandi AS Maggiore P Tarassoli P Sampson B A. Skinner J

Blood metal ions have been widely used to investigate metal-on-metal hip replacements, but their ability to discriminate between well-functioning and failed hips is not known. The Medicines and Healthcare products Regulatory Agency (MHRA) has suggested a cut-off level of 7 parts per billion (ppb). We performed a pair-matched, case-control study to investigate the sensitivity and specificity of blood metal ion levels for diagnosing failure in 176 patients with a unilateral metal-on-metal hip replacement. We recruited 88 cases with a pre-revision, unexplained failed hip and an equal number of matching controls with a well-functioning hip. We investigated the 7 ppb cut-off level for the maximum of cobalt or chromium and determined optimal mathematical cut-off levels from receiver-operating characteristic curves. The 7 ppb cut-off level for the maximum of cobalt or chromium had a specificity of 89% and sensitivity 52% for detecting a pre-operative unexplained failed metal on metal hip replacement. The optimal cut-off level for the maximum of cobalt or chromium was 4.97 ppb and had sensitivity 63% and specificity 86%. Blood metal ions had good discriminant ability to separate failed from well-functioning hip replacements. The MHRA cut-off level of 7 ppb provides a specific test but has poor sensitivity.


The Bone & Joint Journal
Vol. 99-B, Issue 9 | Pages 1147 - 1152
1 Sep 2017
Lainiala O Reito A Jämsä P Eskelinen A

Aims. To determine whether there is any association between glomerular filtration rate (GFR) and blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasty. Patients and Methods. We identified 179 patients with a unilateral 36 mm diameter head as part of a stemmed Summit-Pinnacle MoM hip arthroplasty. GFR was calculated using the Modification of Diet in Renal Disease formula. Results. Normal renal function (GFR ≥ 90 ml/min/1.73 m. 2. ) was seen in 74 patients. Mild renal insufficiency (GFR 60 to 89 ml/min/1.73 m. 2. ) was seen in 90 patients and moderate renal insufficiency (GFR 30 to 59 ml/min/1.73 m. 2. ) in 15. There was no statistical difference in Co and Cr levels between patients with normal renal function and those with mild or moderate renal insufficiency. No correlation was seen between creatinine and blood metal ion levels or between GFR and blood metal ion levels. Linear regression analysis did not show any association between Co and Cr levels and GFR. Conclusion. We did not find any association between GFR and blood metal ion levels. Consequently, the accumulation of Co and Cr in blood due to renal insufficiency does not seem to be a major risk in patients with mild or moderate renal insufficiency. Cite this article Bone Joint J 2017;99-B:1147–52


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1018 - 1024
1 Aug 2018
Ando W Yasui H Yamamoto K Oinuma K Tokunaga H Inaba Y Kobayashi N Aihara M Nakanishi R Ohzono K

Aims. The purpose of this study was to compare two different types of metal-on-metal (MoM) bearing for total hip arthroplasty (THA): one with a large femoral head (38 mm to 52 mm) and the other with a conventional femoral head (28 mm or 32 mm). We compared clinical outcome, blood metal ion levels, and the incidence of pseudotumour in the two groups. Patients and Methods. Between December 2009 and December 2011, 62 patients underwent MoM THA with a large femoral head (Magnum group) and 57 patients an MoM THA with a conventional femoral head (conventional group). Clinical outcome was assessed using the Harris Hip score, University of California, Los Angeles (UCLA) activity score and EuroQol-5D (EQ-5D). Blood metal ion levels were measured and MRI scans were analyzed at a minimum of five years postoperatively. Results. No acetabular component was implanted with more than 50° of inclination in either group. The Harris Hip Score, UCLA activity score, and EQ-5D improved postoperatively in both groups; no significant clinical differences were noted between the groups. The blood cobalt ion levels in the conventional group continued to rise postoperatively to five years while reaching a plateau at two years postoperatively in the Magnum group. At five years, the mean cobalt ion level of 1.16 μg/l (. sd. 1.32) in the Magnum group was significantly lower than the 3.77 μg/l (. sd. 9.80) seen in the conventional group (p = 0.0015). The incidence of moderate to severe pseudotumour was 4.7% in the Magnum group and 20.6% in the conventional group. There were no dislocations in the Magnum group and two in the conventional group. One patient in the Magnum group underwent revision for pseudotumour at 4.7 years postoperatively. Conclusion. At five years, a well-positioned large head MoM THA has a significantly lower level of metal ion release and a lower incidence of moderate to severe pseudotumour than a MoM bearing of conventional size. Cite this article: Bone Joint J 2018;100-B:1018–24


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_12 | Pages 44 - 44
1 Jun 2017
Matharu G Berryman F Judge A Reito A McConnell J Lainiala O Young S Eskelinen A Pandit H Murray D
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Recent studies have demonstrated that implant-specific blood metal ion thresholds exist in unilateral and bilateral metal-on-metal (MoM) hip arthroplasty patients, with these thresholds being most effective for identifying patients at low-risk of adverse reactions to metal debris (ARMD). We investigated whether these new blood metal ion thresholds could effectively identify patients at risk of ARMD in an external cohort of MoM hip arthroplasty patients. We performed a validation study involving 803 MoM hip arthroplasties implanted in 710 patients at three European centres (323=unilateral Birmingham Hip Resurfacing (BHR); 93=bilateral BHR; 294=unilateral Corail-Pinnacle). All patients underwent whole blood metal ion sampling. Patients were divided into those with ARMD (revised for ARMD or ARMD on imaging; n=75), and those without ARMD (n=635). Previously devised implant-specific blood metal ion thresholds (cobalt=2.15μg/l for unilateral BHR; maximum cobalt or chromium=5.5μg/l for bilateral BHR; cobalt=3.57μg/l for unilateral Corail-Pinnacle) were applied to the validation cohort, with receiver operating characteristic curve analysis used to establish the discriminatory characteristics for each respective threshold. The area under the curve, sensitivity, specificity, positive predictive value and negative predictive value for distinguishing between patients with and without ARMD for each implant-specific threshold were respectively: unilateral BHR=89.4% (95% CI=82.8%-96.0%), 78.9%, 86.7%, 44.1%, 96.9%; bilateral BHR=89.2% (95% CI=81.3%-97.1%), 70.6%, 86.8%, 54.5%, 93.0%; unilateral Corail-Pinnacle=76.9% (95% CI=63.9%-90.0%), 65.0%, 85.4%, 24.5%, 97.1%. The 7μg/l UK MHRA threshold missed significantly more patients with ARMD compared with the implant-specific thresholds (4.9% vs. 2.8%; p=0.0003). This external multi-centre validation study has confirmed that MoM hip arthroplasty patients with blood metal ion levels below newly devised implant-specific thresholds have a low-risk of ARMD. Compared to implant-specific thresholds, the currently proposed fixed MHRA threshold missed more patients with ARMD. We recommend using implant-specific thresholds over fixed thresholds when managing MoM hip arthroplasty patients


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 307 - 314
1 Mar 2011
Matthies A Underwood R Cann P Ilo K Nawaz Z Skinner J Hart AJ

This study compared component wear rates and pre-revision blood metal ions levels in two groups of failed metal-on-metal hip arthroplasties: hip resurfacing and modular total hip replacement (THR). There was no significant difference in the median rate of linear wear between the groups for both acetabular (p = 0.4633) and femoral (p = 0.0872) components. There was also no significant difference in the median linear wear rates when failed hip resurfacing and modular THR hips of the same type (ASR and Birmingham hip resurfacing (BHR)) were compared. Unlike other studies of well-functioning hips, there was no significant difference in pre-revision blood metal ion levels between hip resurfacing and modular THR. Edge loading was common in both groups, but more common in the resurfacing group (67%) than in the modular group (57%). However, this was not significant (p = 0.3479). We attribute this difference to retention of the neck in resurfacing of the hip, leading to impingement-type edge loading. This was supported by visual evidence of impingement on the femur. These findings show that failed metal-on-metal hip resurfacing and modular THRs have similar component wear rates and are both associated with raised pre-revision blood levels of metal ions


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1231 - 1237
1 Jul 2021
Manninen E Lainiala O Karsikas M Reito A Jämsä P Eskelinen A

Aims. To find out if there is an inverse association between estimated glomerular filtration rate (eGFR) and whole blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasties and renal insufficiency, suggesting that renal insufficiency could cause accumulation of Co and Cr in blood. Methods. Out of 2,520 patients with 3,013 MoM hip arthroplasties, we identified 1,244 patients with whole blood Co, Cr, and creatinine measured within no more than a one-year interval. We analyzed the correlation of blood metal ion levels and eGFR to identify a potential trend of accumulating Co or Cr with decreasing eGFR. Results. Of the 1,244 patients, 112 had normal renal function (eGFR > 90 ml/min/1.73 m. 2. ), 715 had mild renal insufficiency (eGFR 60 to 89), 384 had moderate renal insufficiency (eGFR 30 to 59), 27 had severe renal insufficiency (eGFR 15 to 29), and six had end-stage renal insufficiency (eGFR < 15). Median eGFR was 68 ml/min/1.73 m. 2. (interquartile range (IQR) 56 to 82), median whole blood Co was 3.3 µg/l (IQR 1.1 to 9.9), and median Cr was 2.0 µg/l (IQR 1.2 to 3.6). We did not observe an association between decreased eGFR and increased whole blood Co and Cr concentrations, but instead both increased Co and Cr were associated with higher eGFR, indicating better kidney function. Conclusion. As patients with MoM hip arthroplasties get older, the prevalence of renal insufficiency among them will increase, and orthopaedic surgeons will increasingly have to evaluate whether or not this affects patient follow-up. The USA Food and Drug Administration suggests that closer follow-up may be needed for MoM patients with renal insufficiency. We did not observe accumulation of blood Co or Cr in MoM hip arthroplasty patients with mild to severe renal insufficiency. Cite this article: Bone Joint J 2021;103-B(7):1231–1237


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 17 - 17
1 Jan 2016
Ando W Yamamoto K Aihara M Koyama T Hashimoto Y Tsujimoto T Ohzono K
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Metal on metal total hip arthroplasty (MoM THA) provides the potential improvement in articular wear. However, several adverse events including pseudotumor had been reported. Magnetic resonance imaging (MRI) was considered to be the proposal tool for detection of pseudotumor after MoM THA. In this study, we performed the screening of pseudotumor after MoM THA using the MRI. We studied 43 patients with M2a Magnum® (Biomet) and 34 patients with M2a Taper® (Biomet) of MoM THA from December 2009 to December 2011 with follow-up of 2.5 years (2.0–4.0 years) after surgery. MRI assessments were performed at a mean of 2.1 years postoperatively. Pseudotumor findings were graded using Anderson classification (Skeletal Radiol, 2011: 40; 303). Age, sex, height, weight, Harris Hip Score, EQ5D satisfaction score, UCLA activity score, and blood metal ion levels were evaluated. The prevalence of pseudotumor was 27.2%; 56 normal (Type A), 13 mild (C1), 8 moderate (C2) and none were graded severe (C3). Weight and BMI in the mild group was significantly higher than those in normal. There was no significant difference in age, sex and height among these groups. With regard to Harris Hip score, pain and ROM score in moderate group was significantly lower than that in normal and mild group. EQ5D satisfaction score and UCLA activity score showed not significant differences among groups. 3.01±3.32 μg/L of blood cobalt ion levels in the moderate groups was significantly higher than 0.97±0.64 μg/L in normal group. Blood cobalt ion levels of 1 mild and 2 moderate were over the threshold of 7 μg/L. These patients were implanted with M2a Taper, not M2a Magnum. 14% of the prevalence in the patients with M2a Magnum was significantly lower than 41% in the patients with M2a Taper. No revision surgeries were required. The patients with no pseudotumor did not show the increase of blood metal ion. Contrarily, several patients showed the increase of blood metal ion in case of detecting pseudotumor. MRI assessments were useful for screening of pseudotumor after MoM THA and blood metal ion should be investigated for patients with mild and moderate pseudotumor in MoM THA


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 21 - 21
1 Jul 2020
Nandra R Ahmed U Berryman F Brash L Dunlop D Matharu G
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Introduction. Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in “at-risk” Birmingham Hip Resurfacing (BHR) patients, and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed if patients were not recalled. Methods. All BHR patients subject to the 2015 MHRA recall (all females, and males with head sizes 46mm or below, regardless of symptoms) at one specialist centre were invited for review (707 hips). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data, as was the number needed to treat (NNT) to avoid missing one case of asymptomatic ARMD. Results. The overall institutional surveillance cost to investigate all patients once was £105,922 (range £148 to £258 per patient). The most expensive aspects of surveillance were radiographs (£39,598), advanced nurse practitioner assistance (£23,618), cross-sectional imaging (£14,828), and blood metal ions (£14,825). 31 hips had imaging evidence of ARMD (12 revised, with 19 under surveillance). Seven hips were asymptomatic, however all revisions were symptomatic. The NNT to avoid missing one case of asymptomatic ARMD (on imaging and/or requiring revision) was 101 patients, equating to a screening cost of £18,041 to avoid one case of asymptomatic ARMD. Conclusions. Implementing MHRA surveillance for “at-risk” BHR patients was extremely costly, both financially and logistically. As the risk of asymptomatic ARMD was low, our data suggests the 2015 MHRA surveillance is not cost-effective. We therefore have concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for all metal-on-metal hip arthroplasty patients


The Bone & Joint Journal
Vol. 103-B, Issue 7 Supple B | Pages 73 - 77
1 Jul 2021
Lawrie CM Barrack RL Nunley RM

Aims. Dual mobility (DM) implants have been shown to reduce the dislocation rate after total hip arthroplasty (THA), but there remain concerns about the use of cobalt chrome liners inserted into titanium shells. The aim of this study was to assess the clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) at mid-term follow-up in young, active patients receiving a modular DM THA. Methods. This was a prospective study involving patients aged < 65 years, with a BMI of < 35 kg/m. 2. , and University of California, Los Angeles activity score of > 6 who underwent primary THA with a modular cobalt chrome acetabular liner, highly cross-linked polyethylene mobile bearing, and a cementless titanium femoral stem. Patient-reported outcome measures, whole blood metal ion levels (μg/l), and periprosthetic femoral BMD were measured at baseline and at one, two, and five years postoperatively. The results two years postoperatively for this cohort have been previously reported. Results. A total of 43 patients were enrolled. At minimum follow-up of five years, 23 (53.4%) returned for clinical and radiological review, 25 (58.1%) had metal ion analysis performed, 19 (44.2%) underwent dual energy x-ray absorptiometry scans, and 25 (58%) completed a pain-drawing questionnaire. The mean modified Harris Hip Scores improved significantly from 54.8 (SD 19) preoperatively to 93.08 (SD 10.5) five years postoperatively (p < 0.001). One patient was revised for aseptic acetabular loosening. The mean cobalt levels increased from 0.065 μg/l (SD 0.03) to 0.08 (SD 0.05) and the mean titanium levels increased from 0.35 (SD 0.13) to 0.78 (SD 0.29). The femoral BMD ratio decreased in Gruen Zone 1 (91.9%) at five years postoperatively compared with the baseline scores at six weeks potoperatively. The femoral BMD ratio was maintained in Gruen zones 2 to 7. Conclusion. The use of a modular DM component and a cementless, tapered femoral stem shows excellent mid-term survivorship with minimal concerns for corrosion and metal ion release in a cohort of young, active patients undergoing primary THA. Cite this article: Bone Joint J 2021;103-B(7 Supple B):73–77


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 27 - 27
1 Nov 2015
Berber R Khoo M Carrington R Miles J Skinner J Hart A
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Introduction. Uncertainties in the management of patients with MOM hip implants continue to be a problem for all surgeons. Guidelines vary and do not fully define or quantify thresholds. We aimed to assess the differences in decision-making amongst an international community of six specialist orthopaedic institutions. Methods. Five international tertiary referral orthopaedic units (one UK, two USA, and two European) were invited to participate. Each unit organised an MDT panel consisting of 2 or more hip surgeons and a musculoskeletal radiologist. All units discussed the same 10 patients. A full clinical dataset was provided including blood test and all imaging. Differences in the interpretation of findings, management decision and rationale for decisions were compared between institutions. Results. Asymptomatic patients with metal ions below 7ppb and intra-articular synovitis were collectively treated with monitoring and repeat ion measurement. Symptomatic patients with similar findings were recommended revision surgery by all units. Raised metal ions and a cystic pseudotumour on imaging that is palpable clinically was also consistently recommended revision surgery. Moderate symptoms (OHS 30), 2B pseudotumour, and moderate metal ions (cobalt 5.5ppb) were seen as an indication for revision in 5 units, however the reverse is seen if the patient had several co-morbidities. Further to this, rising blood metal ions (6 to 7.5ppb) was recommended surgery by 4 units, and watchful waiting in 2 units. Rising blood metal ion levels (6ppb to 10ppb) and a small fluid collection on MRI in asymptomatic patients was recommended clinical review and repeat metal ions by 3 units, repeat MRI by 1 unit and revision for suboptimal implant position by the remaining 2 units. Conclusion. Moderate symptoms, blood metal ions and cystic pseudotumours led to inconsistent agreement between institutions. Coordinated international guidance and MDT panel discussions are recommended to improve consensus in decision-making


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 21 - 21
1 Jun 2016
Matharu G Berryman F Brash L Pynsent P Dunlop D Treacy R
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Introduction. We investigated whether blood metal ions could effectively identify bilateral metal-on-metal hip patients at risk of adverse reactions to metal debris (ARMD). Patients and methods. This single-centre, prospective study involved 235 patients (185 bilateral Birmingham Hip Resurfacings (BHRs) and 50 bilateral Corail-Pinnacles) undergoing whole blood metal ion sampling (mean time=6.8 years from latest implant to sampling). Patients were divided into ARMD (revised or ARMD on imaging; n=40) and non-ARMD groups (n=195). Metal ion parameters (cobalt; chromium; maximum cobalt or chromium; cobalt-chromium ratio) were compared between groups. Optimal metal ion thresholds for identifying ARMD patients were determined using receiver operating characteristic (ROC) analysis, which compares the performance of different tests using the area under the curve (AUC) (higher AUC=more discriminatory). Results. All ion parameters were significantly higher (p<0.0001) in ARMD patients versus non-ARMD patients. Maximum cobalt or chromium produced the highest AUC for BHRs (91.0%) and Corail-Pinnacles (71.8%). For BHRs, maximum cobalt or chromium AUC was significantly greater than cobalt-chromium ratio AUC (p=0.019) but not compared to cobalt (p=0.574) or chromium (p=0.721). For Corail-Pinnacles, AUCs for all ion parameters were not significantly different (p>0.160). Optimal ion thresholds for identifying ARMD varied between implants (maximum cobalt or chromium: BHR=5.52µg/l; Corail-Pinnacle=4.04µg/l). Thresholds had good sensitivities (83.3%–90.0%) and specificities (65.0%–88.4%), high negative predictive values (96.3%–96.5%) and lower positive predictive values (39.1%–58.1%). Fixed USA (10µg/l) and UK (7µg/l) authority thresholds missed more hips with ARMD (11–14 hips missed; 4.7–6.0%) compared to Implant Specific Thresholds (6 hips missed; 2.6%). Discussion. Bilateral BHR and Corail-Pinnacle patients with blood metal ions below Implant Specific Thresholds were at low-risk of ARMD. These thresholds could rationalise follow-up resources in asymptomatic patients. Conclusion. Implant Specific Thresholds are preferable to fixed authority thresholds given that Implant Specific Thresholds were more effective for identifying patients at risk of ARMD requiring further investigation


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 128 - 128
1 Feb 2017
Bragdon C Galea V Donahue G Lindgren V Troelsen A Marega L Muratoglu O Malchau H
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Introduction. Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable. The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards. Methods. We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion. Results. The average acetabular inclination angle was found to be 44.7° (20.6°–64.5°), and the average anteversion angle was 24° (0.2°–55.3°) (Figure 1). After controlling for the possible confounding variables, the factors contributing to elevated metal ions (≥ 7 ppb) were found to be time from surgery (OR = 1.29, p = 0.011), high abduction angle (– 55°) (OR = 4.40, p = 0.001), low anteversion angle (0°–10°) (OR = 3.82, p = 0.001), and female gender (OR = 3.45, p = 0.001). Discussion and Conclusion. We found that blood metal ion levels are affected by both acetabular inclination and anteversion (Figure 2). Furthermore, we observed that there was a high degree of variation in the positioning of these implants, and we conclude that those with high inclination and/or low anteversion angle should be most vigilantly monitored


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_12 | Pages 7 - 7
1 Jun 2017
Berber R Abdel-Gadir A Palla L Moon J Manisty C Skinner J Hart A
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Circulating cobalt and chromium from metal-on-metal implants cause rare but fatal autopsy-diagnosed cardiotoxicity. Concern exists that milder cardiotoxicity may be common and under-recognized. Unacceptably high failure rates of metal-on-metal hip implants have prompted regulatory authorities to issue worldwide safety alerts. Despite this, approximately 1 million patients continue to live with metal-on-metal implants, putting them at risk of systemic toxicity. Although blood cobalt and chromium levels are easily measured and track local toxicity, no non-invasive tests for organ deposition exist. We recently demonstrated the utilisation of a T2* protocol (cardiovascular MRI) to detect cobalt and chromium deposition within the liver of a patient with elevated blood cobalt levels (confirmed by liver biopsy tissue analysis and X-ray fluorescence spectroscopy). We sought to detect and constrain the correlation between blood metal ions and a comprehensive panel of established markers of early cardiotoxicity. In addition we applied T2* protocols with the aim of detecting cardiac metal deposition. 90 patients were recruited through RNOH clinics into this prospective single centre blinded study. Patients were divided into 3 age and gender-matched groups according to type of implant and blood metal ion levels as follows: [Group A] Non-metal bearing hip implants; [Group B] Metal-on-metal implants, low blood metal ion levels (<7ppb); and [Group C] Metal-on-metal implants, high blood levels (>7ppb). All underwent detailed cardiovascular phenotyping using cardiac MRI (with T2*, T1 and ECV mapping, in addition to LV size and ejection fraction), advanced echocardiography (LV size and ejection fraction), and cardiac blood biomarker (Troponin and BNP) sampling in the same sitting at the Heart Hospital London. Primary outcomes were pre-specified. See study flow diagram – figure 1. (The study was registered with . clinicaltrials.gov. : NCT02331264). Blood cobalt levels were significantly different between groups (0.17ppb (range 0·10–0·47, SD 0·08) vs. 2·47 (0·72–6·9, SD 1·81) vs. 30·0 (7·54–118.0, SD 29·1) respectively for groups A, B and C). No significant between-group differences were found for LV size, ejection fraction (CMR or echocardiography), LA size, T1, T2*, ECV, BNP or troponin, with all results within normal ranges. There was no relationship between blood cobalt levels and either left ventricular ejection fraction or T2* (r=-0·022 and r=-0·108 respectively). Although small, the study was sufficiently powered to detect, as a minimum, a difference in ejection fraction of 4.8% (Cohen's d effect size 0·8). Using best available technologies, exposure of patients with metal-on-metal hip implants to high (but not extreme) blood cobalt and chromium levels has no detectable effect on the heart. We believe these findings will offer reassurance to one million patients worldwide living with a metal-on-metal hip implant and will support clinicians caring for such patients. For any figures or tables, please contact the authors directly by clicking on ‘Info & Metrics’ above to access author contact details


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 14 - 14
7 Aug 2023
Langton D Bhalekar R Wells S Nargol M Haston S Natu S Nargol A
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Abstract. Introduction. Several studies have reported significant cobalt(Co) and chromium(Cr) elevations in the blood of patients with total-knee-replacements (TKRs), and histological signs of metal sensitivity have been reported in up to 44% of patients undergoing revision of their TKRs. We carried out this investigation to determine the source and quantity of metal release in TKRs. Methodology. We identified all TKRs with polished CoCr trays (N=59) [Vanguard=29, Attune=4 and PFC=26]. These were analysed using peer-reviewed [coordinate-measuring-machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D-profilometry (surface roughness-Ra) and 4D-microscopy. Histological and blood metal ion concentration analyses were performed. Results. The median(IQR) PE wear rate was 10(6to20) mm3/year. Microscopic analysis identified pitting on superior surface of 36(49%) trays. Ra [median (IQR)] of superior surface of pitted trays [0.076 (0.060–0.084) µm] showed a statistically significant increase (p<0.001) compared with unpitted trays [0.057(0.049–0.066) µm]. 4D-microscopy and CMM analysis estimated wear volumes of up to 2mm3 secondary to pitting. The median (range) Co and Cr concentrations were 2.5µg/l (0.2–69.4) and 1.7µg/l (0.5–12.5) respectively in 40 patients. Of the tissue samples examined in 30 patients,6 had at-least “mild”-ALVAL infiltrate. All corresponding “ALVAL” explants were found to be pitted and/or show evidence of loosening of the tray. Conclusion. This study provides further evidence that CoCr release in TKR appears to be an under-recognised cause of adverse clinical outcomes. Gross metal ion elevations occurred in association with micromotion/loosening of the tray


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 12 | Pages 1602 - 1609
1 Dec 2011
Malviya A Ramaskandhan JR Bowman R Hashmi M Holland JP Kometa S Lingard E

The aim of this study was to investigate the possible benefit of large-head metal-on-metal bearing on a stem for primary hip replacement compared with a 28 mm diameter conventional metal-on-polyethylene bearing in a prospective randomised controlled trial. We investigated cemented stem behaviour between these two different bearings using Einzel-Bild-Röntgen-Analyse, clinical and patient reported measures (Harris hip score, Western Ontario and McMaster Universities osteoarthritis index, Short Form-36 and satisfaction) and whole blood metal ion levels at two years. A power study indicated that 50 hips were needed in each group to detect subsidence of > 5 mm at two years with a p-value of < 0.05. . Significant improvement (p < 0.001) was found in the mean clinical and patient reported outcomes at two years for both groups. Comparison of outcomes between the groups at two years showed no statistically significant difference for mean stem migration, clinical and patient reported outcomes; except overall patient satisfaction which was higher for metal-on-metal group (p = 0.05). Metal ion levels were raised above the Medicines and Healthcare products Regulatory Agency advised safety level (7 µg per litre) in 20% of the metal-on-metal group and in one patient in metal-on-polyethylene group (who had a metal-on-metal implant on the contralateral side). Two patients in the metal-on-metal group were revised, one for pseudotumour and one for peri-prosthetic fracture. . Use of large modular heads is associated with a risk of raised whole blood metal ion levels despite using a proven bearing from resurfacing. The head-neck junction or excess stem micromotion are possibly the weak links warranting further research


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 138 - 138
1 Feb 2017
Goderecci R Aloisio A Fidanza A Ciprietti N Francione V Calvisi V
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Introduction. Failure rates of Metal-on-Metal (MoM) ASR XL hip implants have been unacceptably high compared with other bearing surfaces, so patients must be monitored over the time checking for disorders in clinical condition, blood tests or in diagnostic imaging. Objectives. We have carried out a continuing prospective investigation to evaluate the relationship between blood metal ions measurements and ultrasound levels and to evaluate if ultrasound score can predict a future indication to revision. Materials and methods. From DePuy Recall of 2010 we have monitored 106 patients (51 males, 55 females, mean age 63.6) with ASRXL implants. The controls were performed annually. The following scales were used for patients evaluation:. Ultrasound score: 0 none; 1 fluid collection <20 mm, 2 fluid collection <20 mm, 3 solid mass: metallosis. Blood metal levels of Chromium-Cobalt (Cr-Co) (μg/l = ppb): normal <3 ppb, alert between 3 and 7 ppb, pathologic <7 ppb. Clinical Score: Harris Hip Score. Rx score, evaluating the prosthetic-bone integration and the inclination of acetabular component. Patients who presented positive clinical-instrumental conditions and values of Cr and Co > 3 mg/l were checked every 6 months. Statistical analysis was carried out with Non-parametric Kruskal-Wallis test and two factors Analysis of Variance using SAS System vers. 9.4. Results. The follow-up included 110 implants (4 are bilateral case). 43 patients (39,1 %) underwent revision surgery for failed MoM utilizing ceramic-on-polyethylene devices. At a mean time of 65,7 +/− 15,9 months, 47 patients had a ultrasound score of 0 (13 revised), 32 patients had a ultrasound score of 1 (9 revised), 20 patients had a ultrasound score of 2 (15 revised), 7 patients had a ultrasound score of 3 (6 revised); 44 patients had Cr value < 3 ppb (5 revised), 28 patients had Cr value <3 ppb<7 (6 revised), 34 patients had Cr value <7 ppb (32 revised), 25 patients had Co value < 3 ppb (5 revised), 20 patients had Co value <3 ppb<7 (1 revised), 61 patients had Co value > 3 ppb (37 revised). A positive correlation between blood metal ions values and ultrasound levels (p<0,001) and a statistically significant interaction between ultrasound score and indication to revision (p=0,037) were found. Discussion and Conclusion. As reported in literature also in our experience the ASR XL implant was afflicted by an excessive revision rate, associated with levels of metal ions significantly higher than other hip bearing surfaces. Our results demonstrate a positive correlation between blood Cr and Co levels and the amount of fluid collection: at higher levels of fluid collection correspond higher levels of blood metal ions. Since statistical analysis confirmed that the level of ultrasound score is correlated with indication to revision it is suggested to use ultrasounds, if the score is 2 or more, as parameter to revise MoM implants even in absence of pathologic blood ions levels


The Bone & Joint Journal
Vol. 101-B, Issue 9 | Pages 1035 - 1041
1 Sep 2019
Markel DC Bou-Akl T Rossi MD Pizzimenti N Wu B Ren W

Aims. The aim of this study was to evaluate blood metal ion levels, leucocyte profiles, and serum cytokines in patients with a total hip arthroplasty (THA) involving modular dual-mobility components. Patients and Methods. A total of 39 patients were recruited, with clinical follow-up of up to two years. Outcome was assessed using the Harris Hip Score (HHS, the 12-Item Short-Form Health Survey (SF-12), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a visual analogue scale (VAS) for pain. Blood concentrations of cobalt (Co), chromium (Cr), and serum cytokines were measured. Subpopulations of leucocytes were analyzed by flow cytometry. Results. The clinical performance was good. Blood Co levels (ref 1.0 µg/l) were mildly elevated in seven patients at three months, and two patients at two years’ follow-up. The preoperative Cr levels were normal except for one patient with a detectable Cr (1.2 µg/l). Cr levels were detectable in three patients at three months, two patients at one year, and three patients at two years’ follow-up. No patients had symptoms suggestive of failure. Although flow cytometry showed constant circulating leucocyte profiles, there was a significant reduction of serum interleukin (IL)-4, IL-5, and interferon gamma (IFNγ) postoperatively compared with the preoperative levels (p < 0.05). Conclusion. These results suggest that THA using modular dual-mobility components is safe. This allows an opportunity to use a large femoral head and a thick polyethylene bearing surface, which is especially useful in revision procedures or high-risk situations when added stability is required. Cite this article: Bone Joint J 2019;101-B:1035–1041


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 187 - 187
1 Mar 2010
van der Jagt DR Moketi L Nwokeyi K Schepers A
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Whole blood metal ion levels remain a concern in those patients undergoing total hip replacement with metal bearing surfaces. The determination of baseline reference levels are essential if useful information can be gleaned from in vivo studies of functioning implants. We set out to prospectively determine chromium and cobalt metal ion concentrations in patients undergoing total hip replacement to determine reference levels of these metal ions. 100 patients with normal renal function, no occupational or environmental exposure to cobalt and chromium, and an absence of implanted metals were recruited into the study. Metal ion levels were determined using two different assay methods. Both ICP-MS (Inductively Coupled Plasma Mass Spectroscopy) and GFAAS (Graphite Furnace Atomic Adsorption Spectroscopy) are well recognized analytical techniques for the quantification of trace elements. Levels were correlated with gender, age and place of residence. There was considerable variability in whole blood metal ion levels, with the ICPMS being more sensitive and consistent than the GFAAS method. Direct comparison of concentration levels determined by the two methods revealed no significant correlation. There was no correlation with age, gender and place of residence. Our findings would favour the use of the ICP-MS to determine reference levels and as a baseline for metal ion surveillance pre-operatively in patients undergoing metal-on-metal total hip replacements. We also determined that changes in whole blood metal ion levels are more significant than actual levels in patients who have undergone total hip replacement


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 225 - 225
1 Mar 2010
Van Der Jagt D Nwokeyi K Moketi L Schepers A
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Whole blood metal ion levels remain a concern in those patients undergoing total hip replacement with metal bearing surfaces. The determination of baseline reference levels are essential if useful information can be gleaned from in vivo studies of functioning implants. We set out to prospectively determine chromium and cobalt metal ion concentrations in patients undergoing total hip replacement to determine reference levels of these metal ions. 100 patients with normal renal function, no occupational or environmental exposure to cobalt and chromium, and an absence of implanted metals were recruited into the study. Metal ion levels were determined using two different assay methods. Both ICP-MS (Inductively Coupled Plasma Mass Spectroscopy) and GFAAS (Graphite Furnace Atomic Adsorption Spectroscopy) are well recognised analytical techniques for the quantification of trace elements. Levels were correlated with gender, age and place of residence. There was considerable variability in whole blood metal ion levels, with the ICP-MS being more sensitive and consistent than the GFAAS method. Direct comparison of concentration levels determined by the two methods revealed no significant correlation. There was no correlation with age, gender and place of residence. Our findings would favour the use of the ICP-MS to determine reference levels and as a baseline for metalion surveillance pre-operatively in patients undergoing metal-on-metal total hip replacements. We also determined that changes in whole blood metal ion levels are more significant than actual levels in patients who have undergone total hip replacement


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 4 - 4
1 Mar 2010
van der Jagt D Schepers A Nwokeyi K Mokete L
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Purpose: Whole blood metal ion levels remain a concern in those patients undergoing total hip replacement with metal bearing surfaces. The determination of baseline reference levels are essential if useful information can be gleaned from in vivo studies of functioning implants. We set out to prospectively determine chromium and cobalt metal ion concentrations in patients undergoing total hip replacement to determine reference levels of these metal ions. Method: 100 patients with normal renal function, no occupational or environmental exposure to cobalt and chromium, and an absence of implanted metals were recruited into the study. Metal ion levels were determined using two different assay methods. Both ICP-MS (Inductively Coupled Plasma Mass Spectroscopy) and GFAAS (Graphite Furnace Atomic Adsorption Spectroscopy) are well recognized analytical techniques for the quantification of trace elements. Levels were correlated with gender, age and place of residence. Results: There was considerable variability in whole blood metal ion levels, with the ICP-MS being more sensitive and consistent than the GFAAS method. Direct comparison of concentration levels determined by the two methods revealed no significant correlation. There was no correlation with age, gender and place of residence. Conclusion: Our findings would favour the use of the ICP-MS to determine reference levels and as a baseline for metal ion surveillance pre-operatively in patients undergoing metal-on-metal total hip replacements. We also determined that changes in whole blood metal ion levels are more significant than actual levels in patients who have undergone total hip replacement


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1132 - 1141
1 Oct 2022
Holm-Glad T Røkkum M Röhrl SM Roness S Godang K Reigstad O

Aims. To analyze the short-term outcome of two types of total wrist arthroplasty (TWA) in terms of wrist function, migration, and periprosthetic bone behaviour. Methods. A total of 40 patients suffering from non-rheumatoid wrist arthritis were enrolled in a randomized controlled trial comparing the ReMotion and Motec TWAs. Patient-rated and functional outcomes, radiological changes, blood metal ion levels, migration measured by model-based radiostereometric analysis (RSA), bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), complications, loosening, and revision rates at two years were compared. Results. Patient-Rated Wrist and Hand Evaluation (PRWHE) scores, abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) scores, and pain improved similarly and significantly in both groups. Wrist motion improved significantly in the Motec group only, and forearm rotation in the ReMotion group only. Cobalt (Co) and chromium (Cr) blood ion levels were significantly higher in the metal-on-metal (MoM) Motec group than in the metal-on-polyethylene (MoP) ReMotion group. Mean total translation was 0.65 mm (95% confidence interval (CI) 0.26 to 1.12) and 0.27 mm (95% CI 0.14 to 0.47) for the ReMotion carpal and radial components, and 0.32 mm (95% CI 0.22 to 0.45) and 0.26 mm (95% CI 0.20 to 0.34) for the Motec metacarpal and radial components, respectively. Apart from dorsal and volar tilts, which were significantly higher for the radial ReMotion than for the Motec component, no significant differences in absolute migration occurred. BMD around the radial components never returned to baseline. Almost one-third of patients required reoperation due to complications. Two ReMotion implants were revised to Motec TWAs due to carpal component loosening, and three Motec MoM articulations were revised to metal-on-polyether ether ketone due to painful synovitis. Conclusion. Both implants provided matched function and were stable at short-term follow-up, but with a high complication rate. This procedure should be restricted to specialist centres undertaking prospective analysis until its role is clarified. Cite this article: Bone Joint J 2022;104-B(10):1132–1141


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 494 - 494
1 Dec 2013
Pace F Randelli F Serrao L Banci L
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Introduction:. We present the mid-term results of our consecutive series of 155 hips treated with ASR XL Acetabular System (ASR-XL) for large-diameter metal-on-metal total hip arthroplasty and with DePuy ASR Hip Resurfacing System (ASR) for hip resurfacing. Methods:. 114 ASR-XL and 41 ASR were implanted between 2004 and 2008 in 145 patients (69 men and 76 women) with a mean age of 57 years. Twenty-one patients (23 hips) resulted lost to follow-up. All patients were recalled and monitored periodically with clinical, hematological and radiological evaluation. Average follow-up of the 155 hips was 72 months (1 to 104). The mean follow-up, excluding revised patients and those lost to follow-up, was up to 89 months. Results:. At latest follow-up we had revised 54 of 155 hips (35%) with complete removal of ASR device. Revision involved 15 hips with ASR (36.5% within ASR group) and 39 hips with ASR-XL (34.2% within ASR-XL group). Main reasons for revision were aseptic loosening in 24 hips (44%), pain or pain associated with elevation of blood metal ions in 9 (17%), elevation of blood metal ions without pain in 9 (17%), deep infection in 4 hips (7%), recurrent dislocation in 1 hip (2%), periprosthetic fractures in 1 hip (2%), unknown because revised elsewhere in 6 (11%). The cumulative survival with revision for any reason as the end-point for ASR and ASR XL were respectively 59.6% and 59.3%. For patients who did not undergone revision, the mean Harris hip score improved to 91 (57 to 100) at five years and the mean satisfaction after the operation was graded 4.4 in a score from 1 to 5. Metal ions plasma concentration analysis was conducted in 83 patients (87 hips). Elevated metal ion levels (>7 μg/l) was found in 39 patients (42 hips, 48%) with average Cr and Co concentrations respectively of 37.3 μg/l and 81.5 μg/l. The remaining 44 patients (45 hips, 52%) had an average Cr and Co concentrations respectively of 1.2 μg/l and 1.9 μg/l. Metal ion levels in revised patients were significantly (p < 0.001) higher than in non-revised patients. MARS-MRI performed in 38 hips with high metal ions revealed pseudotumour formations in 13 hips (34%). No macroscopic evident clinical sign of cobaltism was reported for any patient. Conclusion:. ASR implants survival could have a considerable drop in the mid-term follow-up due to adverse reactions to high blood metal ions concentrations and metal debris. Adverse reactions could include periprosthetic pseudotumour formations and low-detectable periprosthetic osteolysis even in asymptomatic patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 40 - 40
1 Sep 2012
Oliver MC Railton P Faris P Kinniburgh D Parker R MacKenzie J Werle J Powell J
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Purpose. Elevated blood metal ions are associated with the early failure of the Hip Resurfacing Arthroplasty. The aim of this study was to analyse our prospective database of Hip Resurfacing Arthroplasty patients, to independently review the outliers with elevated blood metal ions and to determine whether a screening program would be of value at our institution. Method. In 2004 a ten year prospective longitudinal study was set up to evaluate the clinical effectiveness and safety of Metal on Metal Hip Resurfacings in young, active adults with degenerative hip disease. Six hundred and four patients have enrolled in this multi-surgeon prospective study with strict inclusion criteria for Hip Resurfacing Arthroplasty. All have received the same implant design. All have completed validated functional outcome questionnaires at baseline, three and six months, then annually. A sub-cohort of 196 patients underwent whole blood chromium and cobalt analysis at the same time periods. Metal on metal bearings have a running in period of a minimum of six months before a steady state wear pattern is attained. We chose five parts per billion for Cobalt or Chromium as our threshold value. This value corresponds to the workplace exposure limit in the United Kingdom to Cobalt in whole blood. Therefore patients with ion levels greater than five parts per billion after six months were recalled for independent review, including further metal ion analysis. Results. Twenty two patients were recalled. Twenty one patients (32 Hip Resurfacing Arthroplasties) were reviewed. At latest review 11 patients (15 Hip Resurfacing Arthroplasties; eight females) had levels greater than five parts per billion. Mean follow up was 59.8 months (47–78). Mean age at surgery was 48.7 years (37–55). Median femoral component size was 50 millimetres (42–54). Mean acetabular anteversion was 18.3 degrees (−5.2 43.0). Mean acetabular inclination was 46.1 degrees (33.1–57.1). Mean cobalt and chromium levels were 8.82 parts per billion (3.49 18.42) and 9.15 parts per billion (3.79 24.33). Patients with ion levels greater than five parts per billion were associated with inferior functional scores (p= 0.018), inferior hip flexion (p=0.01) and mal-positioned acetabular components (p=0.023). All symptomatic patients were female. Conclusion. It is reassuring that the majority do not have elevated metal ions (185/196; 94.4%). That said, blood metal ion screening of Hip Resurfacing Arthroplasties aids in the early detection of problematic cases. Comprehensive clinical review should follow as patient safety is paramount. The early detection of problematic cases is advantageous to the surgeon and patient. Revision surgery for an established pseudotumour has been found to be technically challenging, often with a poor outcome


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 90 - 90
1 Nov 2016
Su E
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Metal-on-metal (MOM) hip arthroplasty has been associated with a variety of new failure modes that may be unfamiliar to surgeons who traditionally perform metal-on-polyethylene THR. These failure modes include adverse local tissue reaction to metal debris, hypersensitivity to metal debris, accelerated wear/metallosis, pseudotumours, and corrosion. A significant number of patients with metal-on-metal hip arthroplasty may present to surgeons for routine followup, concern over their implant, or frank clinical problems. A common issue with MOM hip arthroplasty that can lead to accelerated wear and failure is implant malposition. Malposition of a hard-on-hard bearing can lead to edge loading and accelerated wear at the articular surfaces, which will lead to elevation in blood metal ion levels and metallosis. Distinct from this failure mode is the possibility of metal hypersensitivity, which is believed to be an immunologically mediated reaction to normal amounts of metal debris. Because a modular MOM THR has multiple junctions and tapers that come into contact with one another, there also is the possibility of non-articular metal debris production and corrosion. This type of corrosion reaction can lead to soft tissue destruction not commonly seen with hip resurfacing. Therefore, it is important for orthopaedic surgeons to be aware of the intricacies of following a metal-on-metal hip arthroplasty and to be able to interpret test results such as metal ion levels and cross-sectional imaging. Furthermore, there is a difference in the incidence of problems depending upon the type of implant: hip resurfacing, small-diameter head metal-on-metal total hip replacement, and large diameter head MOM THR. This presentation will discuss the importance of routine monitoring and followup for patients with MOM THR, as well as the utility of measuring blood metal ion levels. The published risk stratification algorithm from the Hip Society will be reviewed


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 365 - 371
1 Apr 2019
Nam D Salih R Nahhas CR Barrack RL Nunley RM

Aims. Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell (vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. Patients and Methods. This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m. 2. and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (. sd. 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole blood metal ion levels (ug/l), and periprosthetic femoral BMD were measured at baseline, as well as at one and two years postoperatively. Power analysis indicated 40 patients necessary to demonstrate a five-fold increase in cobalt levels from baseline (alpha = 0.05, beta = 0.80). A mixed model with repeated measures was used for statistical analysis. Results. Mean Harris Hip Scores improved from 54.1 (. sd. 20.5) to 91.2 (. sd. 10.8) at two years postoperatively (p < 0.001). All patients had radiologically well-fixed components, no patients experienced any instability, and no patients required any further intervention. Mean cobalt levels increased from 0.065 ug/l (. sd. 0.03) preoperatively to 0.30 ug/l (. sd. 0.51) at one year postoperatively (p = 0.01) but decreased at two years postoperatively to 0.16 ug/l (. sd. 0.23; p = 0.2). Four patients (9.3%) had a cobalt level outside the reference range (0.03 ug/l to 0.29 ug/l) at two years postoperatively, with values from 0.32 ug/l to 0.94 ug/l. The mean femoral BMD ratio was maintained in Gruen zones 2 to 7 at both one and two years postoperatively using this stem design. At two years postoperatively, mean BMD in the medial calcar was 101.5% of the baseline value. Conclusion. Use of a modular DM prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at two years postoperatively demonstrates the necessity of continued surveillance in this cohort. Cite this article: Bone Joint J 2019;101-B:365–371


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 9 | Pages 1169 - 1177
1 Sep 2011
Underwood R Matthies A Cann P Skinner JA Hart AJ

The Articular Surface Replacement (ASR) hip resurfacing arthroplasty has a failure rate of 12.0% at five years, compared with 4.3% for the Birmingham Hip Resurfacing (BHR). We analysed 66 ASR and 64 BHR explanted metal-on-metal hip replacements with the aim of understanding their mechanisms of failure. We measured the linear wear rates of the acetabular and femoral components and analysed the clinical cause of failure, pre-revision blood metal ion levels and orientation of the acetabular component. There was no significant difference in metal ion levels (chromium, p = 0.82; cobalt, p = 0.40) or head wear rate (p = 0.14) between the two groups. The ASR had a significantly increased rate of wear of the acetabular component (p = 0.03) and a significantly increased occurrence of edge loading (p < 0.005), which can be attributed to differences in design between the ASR and BHR. The effects of differences in design on the in vivo wear rates are discussed: these may provide an explanation as to why the ASR is more sensitive to suboptimal positioning than the BHR


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_19 | Pages 30 - 30
1 Dec 2014
Nortje M Hussey D McLennan-Smith R Dymond I Grobler G Dower B Bragdon C Muratoglu O Malchau H
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Introduction:. The ASR™ Articular Surface Replacement and ASR™ XL Metal-on-Metal systems were recalled due to high revision rates at five years. A worldwide clinical follow-up of patients was initiated. This paper summarizes current findings in South Africa (SA) in comparison with those outside SA (OSA). Methods:. Patients were followed annually, or until revision, from 10 clinical centers worldwide. Data collected includes demographic, surgical, radiographic, blood metal ion levels, and patient reported outcome measures (PROM). Results:. There were 715 (353 ASR/336 ASR-XL) hips enrolled in the study; 187 ASR and 32 ASR-XL from South Africa. The average time from index surgery was 6 years (2–10) for both SA and OSA. Since enrollment, 2.7% (19) hips were revised (none from SA) and of these 58% (11) had adverse local tissue reaction. Blood metal Co/Cr ion levels decreased by about 50% post-revision. There was no difference in average blood metal ion levels between patients in SA and OSA. Globally, the average blood cobalt ion level was higher for patients with ASR-XL than patients with ASR. The average cup abduction was 43.2° (20°–65°) with little difference between SA and OSA. The average EQ-5D index for SA patients was 0.93 vs. 0.82 for OSA. Discussion:. Currently, South Africa represented the majority of ASR surface replacement implants in the study, which were predominantly in males. This may have contributed to the higher PROM scores in SA compared to the OSA. While no revisions were reported from SA in this study so far, metal ion levels were lower after revision surgery


Bone & Joint Research
Vol. 6, Issue 2 | Pages 113 - 122
1 Feb 2017
Scholes SC Hunt BJ Richardson VM Langton DJ Smith E Joyce TJ

Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. Methods. In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels. Results. The mean wear rate of the articulating surfaces of the heads and acetabular components of all six joints tested was found to be 6.1 mm. 3. /year (4.1 to 7.6). The mean wear rate of the femoral head tapers of the five THAs was 0.054 mm. 3. /year (0.021 to 0.128) with a mean maximum wear depth of 5.7 µm (4.3 to 8.5). Conclusion. Although the taper wear was relatively low, the wear from the articulating surfaces was sufficient to provide concern and was potentially large enough to have been the cause of failure of these joints. The authors believe that patients implanted with the ReCap system, whether the resurfacing prosthesis or the THA, should be closely monitored. Cite this article: S. C. Scholes, B. J. Hunt, V. M. Richardson, D. J. Langton, E. Smith, T. J. Joyce. Explant analysis of the Biomet Magnum/ReCap metal-on-metal hip joint. Bone Joint Res 2017;6:113–122. DOI: 10.1302/2046-3758.62.BJR-2016-0130.R2


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 99 - 99
1 May 2016
Ziaee H Daniel J Matharu G Pynsent P McMinn D
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Blood metal ion sampling can help detect poorly functioning metal-on-metal hip arthroplasties (MoMHA's) requiring revision. Little is known about the variation in these levels following bearing exchange. This study aimed to determine the changes that occur in blood and urine metal ion concentrations following MoMHA revision. A single-centre prospective cohort study was undertaken between 2005 and 2012 of patients with failing large-diameter MoMHA's and high blood metal ions requiring revision to non-metal-on-metal articulations. All patients had normal renal function. Whole blood and urine were collected for metal ion analysis preoperatively and regularly following revision. Twenty-three MoMHAs (21 hip resurfacings and 2 total hip arthroplasties; mean age 56.0 years and 65% female) were revised at a mean time of 7.9 years (range 2.0–14.5 years) from primary surgery. All revisions were performed by the senior author using primary total hip implants (12 ceramic-on-polyethylene bearings, 10 oxinium-on-polyethylene bearings, and 1 metal-on-polyethylene bearing implanted). Mean (range) metal ion concentrations pre-revision were: blood cobalt 13.9µg/l (1.32–74.7µg/l), blood chromium 8.9µg/l (1.29–57.3µg/l), urine cobalt 104.6µg/24 hours (4.35–747.3µg/24 hours), urine chromium 33.2µg/24 hours (4.39–235.4µg/24 hours). After revision the mean metal ion concentrations (percentage of pre-revision values) were: blood cobalt at 2 days=10.7µg/l (77%), 6 days=7.7µg/l (55%), 2 months=3.4µg/l (24%), 1 year=1.0µg/l (7%), 2 years=0.42µg/l (3%); blood chromium at 2 days=8.7µg/l (98%), 6 days=5.5µg/l (62%), 2 months=2.2µg/l (25%), 1 year=1.5µg/l (16%), 2 years=0.97µg/l (11%); urine cobalt at 2 days=31.9µg/24 hours (30%), 6 days=21.5µg/24 hours (21%), 2 months=6.1µg/24 hours (6%), 1 year=0.99µg/24 hours (1%), 2 years=0.61µg/24 hours (1%); urine chromium at 2 days=34.4µg/24 hours (103%), 6 days=15.8µg/24 hours (48%), 2 months=9.3µg/24 hours (28%), 1 year=2.8µg/24 hours (8%), 2 years=1.9µg/24 hours (6%). Following MoM revision cobalt levels decline rapidly in an exponential pattern with a single rate of decay through the 2 year period, reaching reference levels within the first year. Chromium follows a similar pattern but starts lower and takes longer. Renal response to cobalt returns to reference level within days of revision


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 542 - 542
1 Dec 2013
Su E Housman LR Masonis J Noble JW
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Background. Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first hip resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant. Methods. Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years. Results. 265 patients have been enrolled thus far with 193 males; 28 patients have had bilateral procedures. The average age of the patients is 51.3 years (range 22–72). There have been 7 revisions (2.4%) in the entire cohort to date: 2 were for femoral neck fracture, 2 were for acetabular loosening; 1 was for femoral head osteonecrosis; 1 was revised on the day of surgery for errant implant placement; and 1 was for pseudotumor. K-M survival curves for the cohort are 97.8% at 5 years (Figure 1); men had 99% survival, while women had 94.5%. Whole blood metal ion analysis revealed a median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. There was a significant difference between the metal levels in men and women, however women also had smaller component sizes. Furthermore, a significantly higher percentage of female patients had outlier metal ion levels > 7 ppb. Conclusions. This hip resurfacing device has demonstrated safety and efficacy comparable to THR, in this multicenter postmarket approval study. A gender difference in the survival rate and median metal ion levels does exist; therefore, it is important to continue close monitoring of this cohort to determine longer term results


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 100 - 100
1 Feb 2017
Bragdon C Donahue G Lindgren V Galea V Madanat R Muratoglu O Malchau H
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Introduction. Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA. The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA. Methods. The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR. Results. Eighty-nine hips (11%) were revised during the study period. Forty-five of the 338 men underwent revision (13%), and 44 of the 391 women underwent revision (11%). The mean time from index surgery to revision was 7 years for both males and females. After controlling for confounding variables, the only variables found to be associated with revision surgery in patients with unilateral THA were VAS pain (hazard ratio [HR], 1.28; p < 0.001) and elevated cobalt metal ion levels (HR, 1.02; p < 0.001). Patients with bilateral arthroplasties with low HHS (HR, 0.96; p < 0.001) and high cobalt levels (HR, 1.02; p < 0.001) were at increased risk for revision. Moderate-to-severe ALTRs were identified in 48 of the 133 hips with MARS MRI (36%), 17 of which were in females (30% of females) and 31 in males (40% of males). The only variables found to be associated with the presence of moderate-to-severe ALTR were abduction angle (HR, 0.92; p = 0.004) and Corail AMT stem type (HR, 2.31; p = 0.012). Female gender did not influence the risk of revision or ALTR. Chromium concentrations were greater in female patients than males, while cobalt levels were similar between genders. Males reported higher HHS, EQ-5D and UCLA scores than females. Discussion and Conclusion. Both males and females with MoM THA implants should be followed with equal vigilance as gender does not appear to be associated with poor outcomes, such as revision surgery and presence of ALTR


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 25 - 25
1 Nov 2015
Matharu G Daniel J Ziaee H Pynsent P McMinn D
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Introduction. Little is known about variations in blood metal ions following bearing exchange for poorly functioning metal-on-metal hip replacements (MoMHRs). This study aimed to determine the changes that occur in blood and urine metal ion concentrations following MoMHR revision. Methods. Between 2005–2012, a single-centre prospective cohort study was undertaken of patients with large-diameter MoMHRs and high blood metal ions requiring revision. Whole blood and urine were collected both pre-revision and post-revision for metal ion analysis. Results. Twenty-three MoMHRs (21 hip resurfacings and 2 total hip replacements) were revised at a mean time of 7.9 years from primary surgery (mean age 56.0 years; 65% female). All revisions were performed using primary total hip implants and non-metal-on-metal bearings. Mean (range) metal ion concentrations pre-revision were: blood cobalt 13.9µg/l (1.32–74.7µg/l), blood chromium 8.9µg/l (1.29–57.3µg/l), urine cobalt 104.6µg/24 hours (4.35–747.3µg/24 hours), urine chromium 33.2µg/24 hours (4.39–235.4µg/24 hours). After revision the mean metal ion concentrations (percentage of pre-revision values) were: blood cobalt at 2 days=10.7µg/l (77%), 4 days=8.4µg/l (61%), 6 days=7.7µg/l (55%), 2 months=3.4µg/l (24%), 1 year=1.0µg/l (7%), 2 years=0.42µg/l (3%); blood chromium at 2 days=8.7µg/l (98%), 4 days=6.5µg/l (73%), 6 days=5.5µg/l (62%), 2 months=2.2µg/l (25%), 1 year=1.5µg/l (16%), 2 years=0.97µg/l (11%); urine cobalt at 2 days=31.9µg/24 hours (30%), 4 days=22.5µg/24 hours (22%), 6 days=21.5µg/24 hours (21%), 2 months=6.1µg/24 hours (6%), 1 year=0.99µg/24 hours (1%), 2 years=0.61µg/24 hours (1%); urine chromium at 2 days=34.4µg/24 hours (103%), 4 days=19.2µg/24 hours (58%), 6 days=15.8µg/24 hours (48%), 2 months=9.3µg/24 hours (28%), 1 year=2.8µg/24 hours (8%), 2 years=1.9µg/24 hours (6%). Discussion. The most dramatic reductions in systemic metal ion concentrations in MoMHR patients occur early following bearing exchange, with little variation after one-year. Conclusions. Blood and urine metal ion sampling performed as early as two-months following MoMHR revision is sufficient to determine the success of bearing exchange


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1040 - 1044
1 Aug 2013
Kazi HA Perera JR Gillott E Carroll FA Briggs TWR

We prospectively assessed the efficacy of a ceramic-on-metal (CoM) hip bearing with uncemented acetabular and femoral components in which cobalt­–chrome acetabular liners and alumina ceramic heads were used. The cohort comprised 94 total hip replacements (THRs) in 83 patients (38 women and 45 men) with a mean age of 58 years (42 to 70). Minimum follow-up was two years. All patients had pre- and post-operative assessment using the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), Oxford hip score and Short-Form 12 scores. All showed a statistically significant improvement from three months post-operatively onwards (all p < 0.001). After two years whole blood metal ion levels were measured and chromosomal analysis was performed. The levels of all metal ions were elevated except vanadium. Levels of chromium, cobalt, molybdenum and titanium were significantly higher in patients who underwent bilateral THR compared with those undergoing unilateral THR (p < 0.001). Chromosomal analysis demonstrated both structural and aneuploidy mutations. There were significantly more breaks and losses than in the normal population (p < 0.001). There was no significant difference in chromosomal aberration between those undergoing unilateral and bilateral procedures (all analyses p ≥ 0.62). The use of a CoM THR is effective clinically in the short-term, with no concerns, but the significance of high metal ion levels and chromosomal aberrations in the long-term remains unclear. Cite this article: Bone Joint J 2013;95-B:1040–44


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 1 - 1
1 Sep 2012
Ramaskandhan J Malviya A Bowman R Lingard E Holland J
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Introduction. Cemented stems have shown 90–100% survivorship when coupled with polyethylene acetabular component. This study aims to compare cemented stem behaviour in combination with large metal on metal (MOM) vs. metal on poly (MOP) bearings. Patients and Methods. 100 patients were recruited into a single centre RCT (we required 40 in each group for power .90 to confirm stem subsidence of >0.5mm at 2 years; p< 0.05). Recruits were randomized to MOP (28mm) or MOM femoral heads with CPCS cemented femoral stem. Assessments included X-rays (AP pelvis), Harris Hip Scores, blood metal ion levels and patient questionnaires (WOMAC, SF-36, satisfaction questionnaire). Evaluations were done pre-operatively and 3, 12 and 24 months post operatively; blood metal ion measures at 1 year. Results. There were 50 patients in each arm of study matched for age (64 ± 8.5) and BMI (29.04 ±5.5). There was no difference in femoral stem subsidence at 2 years 1.34 (±1.3) and 1.4 (±1.2) mm for MOM and MOP respectively (p=0.88). There was significant improvement in HHS from pre-op to 3 months: 41 to 87 for MOM and 44 to 86 for MOP (p=0.00). This was maintained with no difference between groups at 2 years (p=0.74). Similar pattern was seen for WOMAC and SF-36 scores for both groups at 2 years (p>0.05). Increased blood Cobalt and Chromium levels were observed in 17% and 0% for MOM and MOP group. MOM group reported better patient satisfaction for overall (91% vs. 79%), pain relief (82% vs 66%) and improvement in ADL activities (94% vs.70%) at 2 years. Conclusions. There were no significant differences between groups for stem behavior, clinical and patient reported outcomes. Despite higher patient satisfaction reported by MOM patients, increased metal ion levels had raised concerns regarding the use of MOM bearings with cemented stems for primary THR


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 65 - 65
1 May 2012
Hart A Lloyd G Sabah S Sampson B Underwood R Cann P Henckel J Cobb PJ Lewis A Porter M Muirhead-Allwood S Skinner J
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SUMMARY. We report a prospective study of clinical data collected pre, intra and post operation to remove both cup and head components of 118 failed, current generation metal on metal (MOM) hips. Whilst component position was important, the majority were unexplained failures and of these the majority (63%) had cup inclination angles of less than 55 degrees. Poor biocompatibility of the wear debris may explain many of the failures. BACKGROUND. Morlock et al reported a retrospective analysis of 267 MOM hips but only 34 head and cup couples (ie most were femoral neck fractures) and without data necessary to define cause of failure. The commonest cause of failure in the National Joint Registry (NJR) is unexplained. METHODS. We categorised the cause of failure, as defined by the NJR, of all MOM hips received over an 18 month period that had a full set of pre, intra and post op data. A group of 40 patients with unilateral well functioning MOM hips was used for comparison. RESULTS. In the retrieval group, the median age was 61 years (25 to 87) and there were 80 females and 38 males. The median time between primary and revision operation was 35 months (4 to 121). Femoral head size was <50mm in 89 and >=50mm in 29. The causes of failure were: unexplained in 75; aseptic loosening (acetabular) in 12; aseptic loosening (femoral) in 7; dislocation/subluxation in 1; infection in 11; periprosthetic femoral fracture in 2; malalignment in 6; size mismatch in 3; other in 1. 47 (63%) of unexplained failures had cup inclination angles of less than 55 degrees. The unexplained failures had increased blood metal ions (p <0.0001) and cup inclination angle (p <0.005) but a decreased femoral head size (p <0.0001) when compared to well functioning MOM hip patients. CONCLUSION. The commonest cause of failed MOM hips was unexplained. Comparison to well functioning hips revealed that the mechanism may involve high blood metal ions but high cup inclination angle was not found in the majority of cases. Further biological and mechanical investigation into the underlying mechanism of failure is required


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 9 | Pages 1134 - 1141
1 Sep 2009
Isaac GH Brockett C Breckon A van der Jagt D Williams S Hardaker C Fisher J Schepers A

This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 310 - 310
1 Mar 2013
Randelli F Banci L Visentin O Aliprandi A Randelli G
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We present the mid-term results of our consecutive series of 155 hips treated with ASR extra-large (XL) Acetabular System (ASR XL) and with ASR Hip Resurfacing System (ASR). We reviewed the clinical records of patients with implanted ASR or ASR XL. All patients were recalled and invited to come to our hospital for a periodic clinical, hematological and radiological evaluation.114 ASR XL and 41 ASR were implanted between 2004 and 2008 in 145 patients (69 men and 76 women) with a mean age of 57 years. 21 patients (23 hips) were lost from follow-up. Average follow-up was 76 months (50 to 91). Up now 42 ASR implants have been revised (27.0%): revision involved 9 hips on 41 treated with resurfacing (21.9%) and 33 hips on 114 treated with XL total hip arthroplasty (28.9%). Main reasons for revision were aseptic loosening with or without metallosis in 23 hips (56%), infection in 3 hips (7%), recurrent dislocation in 1 hip (2%), periprosthetic fractures in 1 hip (2%), elevation of blood metal ion in 6 (14%), pain in 2 (5%), unknown in 6 (14%). The cumulative survival for our ASR implants series was 61.6% with revision for any reason as the end-point after a mean follow-up of 76 months. The cumulative survival with revision for any reason as the end-point for ASR and ASR XL were respectively 67.0% and 59.1%. For patients who did not undergone revision, the mean Harris hip score improved to 91 (57 to 100) at five years and the mean satisfaction after the operation was graded 4.4 in a score from 1 to 5. Periprosthetic osteolysis was not found around any unrevised hip. Average cup inclination was 48° for the functioning hips and 55° for the revised hips. Metal ions plasma concentration analysis was conducted in 83 patients (87 hips). Elevated metal ion concentration (>7 μg/l) was found in 39 patients (42 hips, 48%) with average plasma concentrations of 37.3 μg/l for chromium and 81.5 μg/l for cobalt. Lower metal ions levels (<7 μg/l) were found in 44 patients (45 hips, 52%) with average plasma concentrations of 1.2 μg/l for chromium and 1.9 μg/l for cobalt. Our current concerns involve our large series of 30 asymptomatic patients (31 hips) with a radiographically stable implant without osteolysis signs but with elevated blood metal ion concentrations


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVIII | Pages 55 - 55
1 May 2012
Mellon SJ Kwon Y Simpson DJ Murray DW Gill HS
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Introduction. Metal-on-metal (MoM) hip resurfacing arthroplasty is a popular choice for young and active patients. However, there are concerns recently regarding soft tissue masses or pseudotumours. The appearance of these complications is thought to be related blood metal ion levels. The level of metal ions in blood is thought to be the result of MoM wear. In the present study the contribution of acetabulum orientation to stress distribution was investigated. Methods. Four subjects with MoM resurfacings and with known blood metal ion levels underwent motion analysis followed by CT scans. The positions of the acetabular (cup) and femoral components were determined the CT data relative to local coordinate systems in the pelvis (PCS) and the femur (FCS). Transformations, calculated from the motion analysis data, between the PCS and FCS gave the position of the cup relative to the femoral component for each frame of captured motion data. Hip reaction forces were taken from published data1. The intersection of hip reaction force with each subject's cup and the increase in inclination required to move the force to the edge of the cup was calculated for 2% intervals during the stance phase of gait. Finite element models representing each subject's cup and femoral components were created and contact stresses were determined for the native cup inclination angle. For each model, the effect of increasing the inclination of the cup, by up to 10°, in 1° increments, was determined. Results and Discussion. The two subjects with high metal ion levels had inclination angles of 60.2° and 53.7° whereas the two with low metal ion levels had inclination angles of 45.6° and 46.5°. The subjects with high metal ion levels required very little increase to their inclination angle to cause the hip reaction force vector to intersect at the edge. The contact stress on the cup increased dramatically when the inclination angle was such that the hip reaction force intersected with the edge. The average increase in contact stress under edge-loading conditions was 57% for the two subjects with high metal ions. In contrast, the subjects with low metal ions exhibited no change in contact stress when the inclination angle of their cups was increased by 10°. The inter-subject variability in the measured hip reaction forces was greater than the amount of increase in cup inclination required to induce edge-loading for the subjects with high metal ion levels. These results suggest that poor positioning of the cup during surgery may result in edge-loading, a greater rate of wear and adverse biological reactions associated with metal ion release


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_II | Pages 158 - 158
1 Feb 2003
Nolan J Darrah C Fairman B Fleming J
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This prospective study evaluates the outcome of a new metal -on-metal total hip replacement in a younger group of patients. Fifty-five primary all-metal total hip replacements (THR) were evaluated prospectively at a follow-up of 2.8–5.5 years. Patients were selected according to age and activity levels. The mean age was 58 years (41–69). 33 males and 22 females were included in the study. Surgery was carried out for osteoarthritis in 52 patients and for non-union fractured femoral neck, ankylosing spondilitis and post slipped upper femoral epiphysis in the three remaining patients. A single surgeon (the senior author) through the posterior approach carried out the surgery. All patients received the porous coated titanium shell with a Morse taper cobalt chrome liner and double wedge tapered polished cobalt chrome stem and modular head. Blood metal ion analysis was performed on a cohort of 24 patients using High Resolution Inductively Coupled Plasma Mass Spectrometry, sampling taken preoperatively and then repeated post operatively at 6 months, 1 year and then annually. Clinical results have been excellent. X rays show Harris A cementation in all femurs, with no component migration or radiolucencies being identified on follow-up radiographs. No prosthesis to-date has required revision. One patient has died and one is lost to follow up. The following non-device related complications were reported in the group, 2 (4%) superficial wound infections, 1 (2%) dislocation, 1 (2%) thrombosis, 1 (2%) IT band defect and 2 (4%) impingement. The dislocation was treated with a closed reduction. The impingement has resolved by one year in both patients. The results of the pre and postoperative blood metal ion analysis demonstrate some elevated levels, these levels being similar to those previously reported in the literature. The hybrid all-metal THR may represent a valuable alternative in the younger, high demand patient


Bone & Joint Research
Vol. 5, Issue 9 | Pages 370 - 378
1 Sep 2016
Munir S Oliver RA Zicat B Walter WL Walter WK Walsh WR

Objectives. This study aimed to characterise and qualitatively grade the severity of the corrosion particles released into the hip joint following taper corrosion. Methods. The 26 cases examined were CoC/ABG Modular (n = 13) and ASR/SROM (n = 13). Blood serum metal ion levels were collected before and after revision surgery. The haematoxylin and eosin tissue sections were graded on the presence of fibrin exudates, necrosis, inflammatory cells and corrosion products. The corrosion products were identified based on visible observation and graded on abundance. Two independent observers blinded to the clinical patient findings scored all cases. Elemental analysis was performed on corrosion products within tissue sections. X-Ray diffraction was used to identify crystalline structures present in taper debris. Results. The CoC/ABG Modular patients had a mean age of 64.6 years (49.4 to 76.5) and ASR/SROM patients had a mean age of 58.2 years (33.3 to 85.6). The mean time in situ for CoC/ABG was 4.9 years (2 to 6.4) and ASR/SROM was 6.1 years (2.5 to 8.1). The blood serum metal ion concentrations reduced following revision surgery with the exception of Cr levels within CoC/ABG. The grading of tissue sections showed that the macrophage response and metal debris were significantly higher for the ASR/SROM patients (p < 0.001). The brown/red particles were significantly higher for ASR/SROM (p < 0.001). The taper debris contained traces of titanium oxide, chromium oxide and aluminium nitride. Conclusion. This study characterised and qualitatively graded the severity of the corrosion particles released into the hip joint from tapers that had corrosion damage. Cite this article: S. Munir, R. A. Oliver, B. Zicat, W. L. Walter, W. K. Walter, W. R. Walsh. The histological and elemental characterisation of corrosion particles from taper junctions. Bone Joint Res 2016;5:370–378. DOI: 10.1302/2046-3758.59.2000507


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_I | Pages 64 - 64
1 Jan 2003
Nolan J Darrah C
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Fifty five primary Ultima® hybrid all-metal (Johnson & Johnson Professional DePuy) total hip replacements (THR) were evaluated prospectively at a mean follow up of 24 months. Patients were selected according to age and activity levels. The mean age at surgery was 58 years (41–69 years). 33 males and 22 females were included in the study. Surgery was carried out for osteoarthritis in 52 patients and for non-union fractured neck of femur, ankylosing spondilitis and post slipped upper femoral epiphysis in the three remaining patients. A single surgeon (the senior author) through the posterior approach carried out surgery. All patients received the Ultima® porous coated titanium shell with a morse taper cobalt chrome liner and double wedge taper polished stem and modular head. Blood metal ion analysis was performed on a cohort of 24 patients using High Resolution Inductively Coupled Plasma Mass Spectrometry, sampling taken pre operatively and then repeated post operatively at 6 months, 1 year and then annually. Clinical results reported at a mean follow-up interval of 2.016 years have been excellent, with no prosthesis to-date requiring revision and no component migration or radiolucuencies being identified on any follow-up radiographs. One patient has died and one is lost to follow-up. The following non-device related complications were reported in the group, 2 (4%) superficial wound infections, 1 (2%) dislocation, 1 (2%) thrombosis, 1 (2%) IT band defect and 2 (4%) impingement. The dislocation was treated with a closed reduction, the position of the component having been judged as satisfactory. The impingement has resolved by one year in both patients. The results of pre and postoperative blood metal ion analysis in a cohort of 24 patients demonstrate some elevated levels, these levels are similar to those previously reported in the literature. The Ultima® hybrid all-metal THR may represent a valuable alternative in the younger, high demand patient


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 124 - 124
1 Mar 2021
Jelsma J Schotanus M Kleinveld H Grimm B Heyligers I
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An increase in metal ion levels is seen after implantation of all MoM hip prosthesis due to release from the surface directly, more so during articulation and corrosion of the bearing surfaces. The bearing surfaces in MoM prosthesis consist of cobalt, chromium and molybdenum. Several case-reports of cobalt toxicity due to a MoM prosthesis have been published in the last decade. Cobalt intoxication may lead to a variety of symptoms: neuro-ocular toxicity (tinnitus, vertigo, deafness, blindness, convulsions, headaches and peripheral neuropathy), cardiotoxicity and thyroid toxicity. Nausea, anorexia and unexplained weight loss have been described. Systemic effects from metal ions even with well functioning implants or with ion concentrations lower than those associated with known adverse effects may exist and warrant investigation. The aim of this study is to investigate self-reported systemic complaints in association with cobalt ion concentrations in patients with any type of MoM hip prosthesis. A cohort study was conducted. Patients with both unilateral and bilateral, resurfacing and large head metal on metal total hip arthroplasties were included for the current study. Blood metal ion concentrations (cobalt and chromium) were measured by inductively coupled plasma mass spectrometry (ICP-MS). Based on the known cobalt toxicity symptoms of case-reports and toxicology reports a new non-validated questionnaire was developed. questions were subdivided in general questions/symptoms, vestibular symptoms, neurological symptoms, emotional health and cardio- and thyroid toxicity symptoms. Independent samples T test, Fishers Exact Test and Pearsons (R) correlation were used. Analysis was performed on two groups; a low cobalt ion concentration group and a high cobalt ion concentration group A total of 62 patients, 36 (58%) men and 26 (42%) women, were included with a mean age at surgery of 60.8 ± 9.3 years (41.6 – 78.1) and a mean follow up of 6.3 ± 1.4years (3.7 – 9.6). In these patients a total of 71 prosthesis were implanted: 53 unilateral and 9 bilateral. Of these, 44 were resurfacing and 27 large head metal on metal (LHMoM) total hip arthroplasties. Mean cobalt and chromium ion concentrations were 104 ± 141 nmol/L (9 – 833) and 95 ± 130nmol/L (6 – 592), respectively. Based on the different thresholds (120 – 170 or 220 nmol/L) the low cobalt ion concentration group consisted of 44 (71%), 51 (82%) or 55 (89%) subjects respectively. No differences were found in general characteristics, independently of the threshold. The composite score of vestibular symptoms (vision, hearing, tinnitus, dizziness) was significantly higher (p < .050) in all high cobalt ion concentrations groups, independent of the threshold value This study aimed to detect a trend in self-reported systemic complaints in patients with metal-on-metal hip arthroplasty due to raised cobalt ion concentrations. Vestibular symptoms were more common in high cobalt ion concentration groups independent of the three threshold levels tested. The upper limit of acceptable cobalt ion concentrations remains uncertain. With regards to proactively inquired, self-reported symptoms the threshold where effects may be present could be lower than values currently applied in clinical follow-up. It is unknown what exposure to elevated metal ion concentrations for a longer period of time causes with aging subjects. Further research with a larger cohort and a more standardized questionnaire is necessary to detect previously undiscovered or under-reported effects


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 6 | Pages 738 - 744
1 Jun 2009
Hart AJ Sabah S Henckel J Lewis A Cobb J Sampson B Mitchell A Skinner JA

We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty. MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55° and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of blood metal ions tended to be higher in painful compared with well-functioning metal-on-metal hips. These three clinically useful investigations can help to determine the cause of failure of the implant, predict the need for future revision and aid the choice of revision prostheses


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 7 - 7
1 Apr 2019
Paulus A Dirmeier S Hasselt S Kretzer P Bader R Jansson V Utzschneider S
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Introduction. It is well-known that wear debris generated by metal-on-metal hip replacements leads to aseptic loosening. This process starts in the local tissue where an inflammatory reaction is induced, followed by an periprosthetic osteolysis. MOM bearings generate particles as well as ions. The influence of both in human bodies is still the subject of debate. For instance hypersensitivity and high blood metal ion levels are under discussion for systemic reactions or pseudotumors around the hip replacement as a local reaction. The exact biopathologic mechanism is still unknown. The aim of this study was to investigate the impact of local injected metal ions and metal particles. Material and Methods. We used an established murine inflammation model with Balb/c mice and generated three groups. Group PBS (control group, n=10) got an injection of 50µl 0.1 vol% PBS-suspension, Group MI (Metal-ion, n=10) got an injection of 50µl metal ion suspension at a concentration of 200µg/l and Group MP (Metal-particles, n=10) got an injection of 50µl 0.1 vol% metal particle suspension each in the left knee. After incubation for 7 days the mice were euthanized and the extraction of the left knee ensued. Followed by immunhistochemical treatment with markers of inflammation that implied TNFα, IL-6, IL-1β, CD 45, CD 68, CD 3, we counted the positive cells in the synovial layer in the left knees by light microscopy, subdivided into visual fields 200× magnified. The statistical analysis was done with Kruskal-Wallis test and a post hoc Bonferroni correction. Results. The Group with metal particles showed significantly elevated inflammatory markers (TNFα, IL-6, IL-1β, CD 68, CD 45) compared to all other groups. Interestingly, CD 3 as a marker for T-lymphocytes showed no increased levels in all groups. The metal ion group showed significant elevated CD 45 expressions compared to the control group. Conclusion. The results clearly demonstrate that especially metal wear particles lead to an intensive inflammatory reaction. The tissue formations in the metal particle group show an osseous destructive behavior in previously demonstrated results, comparable to pseudotumors. But, in this study, the expression of the immunohistological markers CD 3, CD 45 and CD 68 indicate that the tissue consists of leucocytes and macrophages, whereas lymphocytes could not be detected. This might be due to an acute inflammatory reaction, whereas the adaptive immune response by T-lymphocytes seems not (yet) to be activated. Overall it must be stated that solid metal wear particles are responsible for local inflammatory reactions, whereas it is still unknown whether wear particles corrode in vivo and release a potentially high level of locally toxic metal ions


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 3 - 3
1 Aug 2018
Barrack R Nam D Salih R Nahhas C Nunley R
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To assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular dual mobility acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. This was a prospective study of patients  65 years of age, with a BMI  35 kg/m. 2. , and UCLA activity score > 6 who received a modular cobalt chrome acetabular liner, highly cross-linked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. All patients had a minimum of 2-year clinical follow-up. Patient reported outcome measures, whole blood metal ion levels (ug/L), and periprosthetic femur BMD were measured at baseline and at 1- and 2-years postoperatively. 43 patients (30 male, 13 female; mean age 52.6 ± 6.5 years) were enrolled. Harris Hip Scores improved from 54.1 ± 20.5 to 91.2 ± 10.8 at 2 years postoperatively (p<0.001). All patients had radiographically well-fixed components, no patients have sustained an instability event, and no patients have required a return to the operating room or revision procedure. Mean cobalt levels increased from 0.065 ± 0.03 ug/L preoperatively to 0.30 ± 0.51 at 1-year postoperatively (p=0.01), but decreased at 2 years postoperatively to 0.16 ± 0.23 (p=0.2) (Table 1). Four patients (9.3%) had a cobalt level outside the reference range (0.03 to 0.29ug/L) at 2 years postoperatively with values from 0.32 to 0.94. None were symptomatic. The mean femoral BMD ratio was maintained in Gruen zones 2 thru 7 at both 1- and 2-years postoperatively using this stem design (Table 2). At 2 years postoperatively, BMD in the medial calcar was 101.5% of the baseline value. Use of a modular dual mobility prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at 2 years postoperatively demonstrates the necessity of continued surveillance in this cohort. For any figures or tables, please contact authors directly: . barrackr@wustl.edu


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_22 | Pages 40 - 40
1 May 2013
MacDonald S
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Pain following total hip arthroplasty is a relatively rare event. Several series place the incidence of some degree of pain post THA at approximately 5%. A systematic approach to determining etiology will direct treatment. Hip pain can be categorised as:. Extrinsic to the Hip. –. Spine +/− radiculopathy. –. Vascular disease. –. Metabolic (Paget's). –. Malignancy. Intrinsic to the Hip. Intracapsular/Implant. Loosening. Sepsis. Prosthetic failure. Osteolysis. Instability. Thigh pain. Stem tip pain. Hypersensitivity/ALVAL. Extracapsular. Iliopsoas tendonitis. Snapping Hip. Trochanter problems (bursitis). Heterotopic ossification. A full history and appropriate physical exam will direct the clinician. The use of routine radiographs, blood tests, and special tests (i.e., blood metal ions, advanced imaging techniques) will be discussed I detail


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 22 - 22
1 Jun 2016
Davidson J Sabah S Berber R Hothi H Miles J Carrington R Power A Skinner J Hart A
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Introduction. The Birmingham Hip Resurfacing (Smith & Nephew London, UK) is the most popular hip resurfacing (HR) in the UK. However, it is now subject to two Medical Device Alerts (MDA) from the Medicines and Healthcare products Regulatory Agency (MHRA). Patients/Materials & Methods. A cross-sectional survey of primary metal-on-metal hip procedures recorded on the National Joint Registry for England, Wales and Northern Ireland (NJR) until 5. th. November 2013 was performed. Cost-analysis was based on an algorithm for surveillance of HR at a tertiary referral centre and followed previous MHRA guidance. NIHR NHS Treatment costs were used. The local protocol encompassed: patient outcome scoring (Oxford hip score), blood metal ion measurement (cobalt, chromium), cross-sectional imaging (MRI) and discussion at an internet-enabled multidisciplinary team meeting (iMDT) in addition to routine hip surveillance. Results. A total of 33996 patients have Hip Resurfacings in the UK. 18478 have BHR and 9457 are female or small men. Costs:. Cobalt and Chromium levels £34.64. Single site MRI scan £438.91. Review of medical notes is £97.98. New Patient Appointment £137. Every patient requires at least 1 set of blood tests, an MRI and discussion in iMDT in our unit at a minimum cost of £571.53. This excludes clinic appointments; repeat testing, or costs of revision surgery and litigation. Total minimum cost to NHS £5.4 million. Discussion. It is important to not ignore nationally delivered guidance and therefore this patient group now requires comprehensive follow up as described by the MHRA. Other HR devices may now need to be considered to require further follow-up with inherently increased costs to the NHS. Conclusion. We recommend a streamlining of review via regional iMDTs in order to effectively manage MDA's and minimise potential costs


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 24 - 24
1 Jun 2016
Matharu G Judge A Murray D Pandit H
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Introduction. The impact of pseudotumours associated with metal-on-metal hip resurfacings (MoMHRs) within the second decade is unknown. We investigated: (1) the incidence and risk factors for all-cause and pseudotumour revision following MoMHR at 15-years follow-up, and (2) whether risk factors were gender specific. Patients and methods. This single-centre prospective cohort study included 1429 MoMHRs (1216 patients; 40% female) implanted between 1999–2009. All patients were contacted in 2010 and 2012 as per national recommendations. Patients with hip problems and/or suboptimal Oxford Hip Scores (<41/48) underwent cross-sectional imaging and blood metal ion sampling. Revisions were performed as indicated with diagnoses confirmed from operative and histopathological findings. Multi-variate Cox proportional hazard models assessed the association of predictor variables on time to all-cause and pseudotumour revision. Results. Revisions were performed in 180 MoMHRs (111 for pseudotumour; 62%). Incidence and 15-year revision rates were 12.6% and 19.5% (95% CI 16.2%-23.2%) respectively for all-causes, and 7.8% and 14.0% (95% CI 11.0%-17.7%) respectively for pseudotumours. Smaller femoral head sizes (Hazard Ratio (HR)=0.92 (95% CI 0.88–0.97), p=0.003) and implant design (HR=1.55–3.01, p<0.029) significantly increased all-cause revision risk. Female gender (HR=0.49 (95% CI 0.29–0.84), p=0.009) and young age (HR=0.98 (95% CI 0.96–1.00), p=0.020) also significantly increased pseudotumour revision risk but not all-cause revision risk. Risk factors for all-cause and pseudotumour revision were gender specific. In females, smaller femoral head sizes (p=0.014) increased all-cause revision risk, with young age the only predictor of pseudotumour revision (p=0.019). In males, implant design predicted both all-cause (p<0.015) and pseudotumour revision (p=0.001). Discussion. Incidence and revision rates for all-cause and pseudotumour revision were high in the second decade following MoMHR. Revision predictors differed for all-cause compared to pseudotumour revision, and were also gender specific. Conclusion. Current worldwide follow-up recommendations must ensure these factors are appropriately weighted when risk stratifying MoMHR patients for surveillance


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 264 - 264
1 Dec 2013
Nam KW Choi S Nam U Seo K Kim S Kim HJ
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Introduction:. Whole blood metal ion level and clinical outcomes of ceramic-on-metal bearing were comparable to ceramic-on-ceramic THA in this prospective randomized controlled trial. Methods:. We randomized 150 consecutive THA cases at one institution into two groups: Group I and Group II. Group I, 75 cases, received a THA using ceramic-on-metal couplings and Group II, 75 cases, received ceramic-on-ceramic bearing THA. The implant differed only in the bearing surfaces used. We compared the serum levels of cobalt (Co) and chromium (Cr) and functional outcome scores preoperatively, and at 2, 6, and 12 months postoperatively. Results:. The demographics and preoperative Co and Cr levels were similar between the groups. Femoral head size measured 32 and 36 mm and the proportion of each size was similar in both groups. The mean serum cobalt and chromium levels increased significantly at 2 months in Group I (Co p = 0.02, Cr p = 0.04), but no differences noted between groups at 6 and 12 months (Co p > 0.05, Cr p > 0.05). The mean WOMAC hip scores showed comparable improvements at 12 months with no difference between groups. No ceramic fracture has occurred during follow-up period. Discussion & Conclusion:. CoM bearing THA has showed the metal ion levels and the clinical results comparable to CoC couples except for the relatively high metal ion in running-in period


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 99 - 99
1 Feb 2017
Bragdon C Hussey D Madanat R Donahue G Rolfson O Muratoglu O Malchau H
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Introduction. When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines. The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system. Methods. The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable. Results. Only two of the proposed eleven criteria were found to be significant predictors of revision in our logistic regression model; clinical status (as measured by the Harris Hip Score) and blood metal ion levels. By September 2015, 85 patients had been revised. The median MoM risk score for unrevised hips (2.15) was lower compared to revised hips (4.49) (p < 0.001). Receiver operating characteristic analysis yielded good discrimination between all revised and unrevised hips, with an area under the curve of 0.82 (p < 0.001) (Figure 1). A high MoM risk score had 5.8-fold increased odds for revision relative to the moderate risk group (p < 0.001) and a 21.8-fold increased odds for revision compared to the low risk group (p < 0.001). Discussion and Conclusion. The MoM risk score is an effective tool for applying the current risk stratification guidelines to a cohort of patients with a MoM hip replacement. This scoring system is one way to simplify the interpretation of current risk stratification guidelines for patients with MoM hip replacements


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 24 - 24
1 Nov 2015
Matharu G Mellon S Murray D Pandit H
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Introduction. This study aimed to: (1) compare published follow-up guidelines for metal-on-metal (MoM) hip patients and analyse protocols in relation to current evidence, and (2) assess the financial implications of these guidelines. Methods. Follow-up guidance for MoM hips from five national authorities (MHRA in the UK; EFORT; United States FDA; Therapeutic Goods Administration of Australia; Health Canada) were contrasted and critically appraised. Using National Joint Registry (NJR) data (67,363 MoM hips implanted) the cost of annual surveillance for all MoM hips recorded in the NJR was calculated for each protocol. Results. Significant differences existed between recommended guidance, with protocols not reflecting the best available evidence. These include not stratifying patients according to implant type (total hip replacement (THR) or hip resurfacing (HR)) or adverse reaction to metal debris (ARMD) risk factors, using symptoms to decide patient follow-up, and using suboptimal blood metal ion thresholds to identify poorly performing hips. Patients with asymptomatic ARMD lesions, especially HR patients with no ARMD risk factors, would not be identified by most protocols. Vast cost differences exist between protocols when considering annual surveillance of the NJR population. The MHRA guidance was cheapest for annual follow-up (£8,264,064/10,423,296 Euro/$13,717,440). The most expensive protocols were those recommended by the FDA (£22,321,020/28,134,526 Euro/$37,029,889) and EFORT (£22,708,226/28,590,554 Euro/$37,671,431), both approaching three-times the MHRA costs. The FDA protocol was most costly for surveillance of all symptomatic patients (£18,210,816/22,947,840 Euro/$30,228,480), and EFORTs was most costly for asymptomatic HR patients (£8,283,010 / 10,428,250 Euro / $13,735,495). Discussion. Current MoM hip follow-up guidance is not evidence-based. Most protocols lack the sensitivity to detect asymptomatic ARMD lesions. It is also clear that these protocols are not financially sustainable in the long-term. Conclusions. Further work is required to ensure future guidance published by authorities is more unified as well as both clinically and cost effective


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 142 - 142
1 Jan 2013
Matthies A Suarez A Karbach L Isamailly S Henckel J Skinner J Noble P Hart A
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Introduction. Edge loading is a common wear mechanism in Metal-on-Metal (MOM) hip resurfacing and is associated with higher wear rates and the incidence of pseudotumour. The purpose of this study was to develop a method to investigate the contributions of patient, surgical and implant design variables on the risk of edge loading. Method. We created a mathematical model to calculate the distance from the head-cup contact patch to the rim of the cup and used this to investigate the effect of component position, specific design features and patient activity on the risk of edge loading. We then used this method to calculate the contact patch to rim distance (CPRD) for 160 patients having undergone revision of their MOM hip resurfacing in order to identify any possible associations. Results. We identified several variables that reduce the CPRD and increase the risk of edge loading, including; increased cup anteversion and inclination, activities involving increased hip flexion, reduced clearance, reduced hip diameter and reduced cup arc angle. We also determined the threshold cup orientation for edge loading for five resurfacing designs (Figure 1). In patients with failed MOM hip resurfacings, there was a significant correlation between CPRD and both component wear rates (Figure 2) and blood metal ion levels (all p < 0.005). The ASR was associated with increased wear, reduced CPRD, and increased prevalence of edge loading (all p < 0.05). Conclusions. Edge loading is common and difficult to avoid in MOM hip resurfacing. Whilst some designs, such as the ASR, are more susceptible to edge loading, all are unforgiving of suboptimal cup position. Furthermore, common activities involving flexion of the hip result in edge loading even in patients with a well-positioned cup


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 548 - 548
1 Nov 2011
Hart A Davda K Lali F Skinner J Sampson B
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Introduction: Local problems of metal on metal (MOM) hip arthroplasty such as pseudotumours, neck thinning and osteolysis maybe related to concentrations of cobalt and chromium ions in the synovial fluid. There is little reported on these values. Our aim was to determine the range of metal ion levels in synovial fluid, and to investigate the relationship between these samples and simultaneous blood samples. Methods: Synovial fluid and whole blood samples were taken from 30 consecutive patients at the time of revision surgery for a painful MOM hip. Aspirated fluid was not visibly contaminated with blood. Impants were in situ for a mean period of 31 months. All had normal renal function. Samples were analysed using ICP mass spectrometry and compared with 10 samples from patients without implants. Results: The mean (and range) of synovial fluid metal ion levels were 1965 ug/l (30 to 13618) and 6265 ug/l (11 to 81630) for Cobalt and Chromium respectively. There was a good correlation between synovial and blood levels for both cobalt (R=0.65, p = 0.0001) and chromium (R = 0.59, p = 0.006). Discussion and Conclusion: Metal ions in synovial fluid from MOM hips are generated from wear of the bearing surfaces, the correlation with blood metal ion levels, shown in this study, suggest that blood levels may be used as surrogate marker for hip wear rate. Our range of synovial fluid metal ion levels may be useful for those conducting in vitro studies on the biocompatibility of MOM hips


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 74 - 74
1 May 2016
Taniguchi S Hachiya Y Watanabe H Muramatsu K Tanaka K Yoshioka A
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Purpose. Our primary purpose was to study the rate of occurrence and the natural course of pseudotumors in patients who had not required a revision procedure. Our secondary purpose was to see if there is a relationship between serum metal ion analysis and clinical symptoms with metal-on-metal (MOM) hip arthroplasty. Patients and Methods. We used repeated metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) to screen 17 unrevised hips (mean patient age 63.0 years, 43 to 83 years) with pseudotumors and 26 hips (mean patient age 63.2 years, 47 to 83 years) without pseudotumors. Patients with 17 MOM, 17 ceramic-on-polyethylene (COP) and 7 ceramic on ceramic (COC) who had undergone repeated MARS MRI were evaluated with or without any symptoms. We utilized MARS MRI to score the type of pseudotumors using the Hart method. The mean post-operative time to the first MARS MRI scan was 30.0 months (8 to 96), and the time between the first and the second MARS MRI scan was eleven months (6 to 12). Serum Cr and Co ion measurements were undertaken at the time of both MRIs and analyzed only after MOM total hip arthroplasty. Results. The rate of occurrence of pseudotumors was 47.5% with MOM, 33.0% with COP, and 25.0% with COC. There was a significant difference in number of abnormalities between MOM and COP and COC bearing. At the second MRI scan, the grade of severity of pseudotumors had not changed in 40 hips. Two new asymptomatic pseudotumors (MOM:1 case, COP:1 case) were detected and one pseudotumor was downgraded. In 17 patients with pseudotumors, two cases (11.7%) were symptomatic and in 26 patients without pseudotumors, 4 cases (15.3%) were symptomatic, with no significance between the two groups. In 17 patients with MOM cases, only two cases with pseudotumors were symptomatic, and both cases showed elevated blood metal ion levels. However, in these series 13 cases (6 with pseudotumors and 7 without pseudotumors) (76.4%) were overtaken baseline. So there was no significance in terms of metal ion levels with or without pseudotumors. Discussion. Overall, there was the same tendency in terms of occurrence of pseudotumors compared with our previous studies regarding MARS MRI. Pseudotumors can occur in patients with COP and COC bearing secondary to corrosion at modular femoral head neck taper. This feature is similar to pseudotumors seen in patients with a MOM bearing. In general, the characteristics of the pseudotumors hardly changed. Repeated MARS MRI scans within one year after total hip arthroplasty showed little or no variation. On the other hand, in 26 patients without pseudotumors, two new asymptomatic pseudotumors were detected. Moreover, there was no clinically useful association among symptoms, serological markers and the severity of MR findings. In conclusion, MRI abnormalities are present in normal asymptomatic THA and, regardless of the type of bearing surface, the occurrence of pseudotumors suggests that it might originate from head neck junction and indicate subclinical disease


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_29 | Pages 58 - 58
1 Aug 2013
van der Jagt D Wright H Rubin B Mokete L Nwokeyi K Schepers A
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Monitoring the performance of hip replacements post-operatively is tedious and costly, necessitating radiological examinations as well as other specialized examinations such as whole blood metal ion levels. In an effort to control escalating costs, we conducted an ethically approved clinical trial to assess the efficacy of basic acoustic monitoring equipment to asses these implants. Method. An electronic stethoscope was successfully used to record sounds from the hips of participants with different bearing surfaces. The sounds were recorded while conducting a standardized movement sequence. A 5th order Savitzky-Golay filter with a window width of 21 points was used to remove background noise. The recordings were also listened to by ear and three primary classes of sounds were identified. Frequency components contained in the classes were identified using spectrograms and Welch power density spectra. The sounds were correlated with different patient factors including component positioning, BMI and length of time that the implant was in situ. The skewness and kurtosis of the power spectra were calculated and found to be different for each class. Further frequency analysis was conducted with the aid of the discrete wavelet transform. This met with some success as different frequency levels were found in each sound class. Results. All bearing surfaces produced some noise. The most sounds were produced by the ceramic-on-metal group, even though not in the audible range, and those participants with a body mass index in the obese range. Sounds were also detected in the ceramic-on-polyethylene implants. However, no consistent links between these factors and the sounds produced could be identified. Specifically, the lack of correlation between sound occurrence and length of implantation indicates that this technique is not useful in predicting possible failures or future complications in real time. Conclusions. The sounds themselves did not immediately reveal any information about the implants. This method was deemed impractical as a real-time diagnostic technique. Our study though has demonstrated that inexpensive acoustic monitoring devices can monitor noise emissions. Our data needs to be refined to make these investigations reliable and clinically relevant


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 20 - 20
1 Sep 2012
Davda K Masjedi M Hart A Cobb J
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Metal on Metal hip resurfacing (MoM HR) can be an effective operation for the young arthritic hip population. However, errors in cup orientation have been associated with increased wear, circulating blood metal ions, and soft tissue abnormalities that can lead to premature failure of the bearing surface and subsequent revision surgery. While image free computer guidance has been shown to increase surgical accuracy in total hip arthroplasty, the role of image based technology in MoM HR is unclear. In this study, we compared the accuracy of cup orientation in MoM HR performed by either freehand technique or CT based navigation. Seventy five patients (81 hips) underwent either freehand (n=42) or navigation (n=39) surgery, both requiring a three dimensional (3D) CT surgical plan. Surgery was conducted by hip specialists blind to the method of cup implantation until the operation. Deviation in inclination and version from the planned orientation, as well as, number of cups within a 10° safe zone and 5° optimal zone of the target position was calculated using post operative 3D CT analysis. Error in inclination was significantly reduced with navigation compared to freehand technique (4° vs 6°, p=0.02). We could not detect a difference between the two groups for version error (5° vs 7°, p=0.06). There was a significantly greater number of hips within a 10° (87% vs 67%, p=0.04) and 5° (50% vs 20%, p=0.06) safe zone when navigated. Image based navigation can substantially improve accuracy in cup orientation. The results of our freehand group appear better than historic controls, suggesting the use of a 3D plan may help to reduce technical error and improve the learning curve in this technically demanding procedure. We advocate the use of image based navigation in MoM hip resurfacing arthroplasty


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 28 - 28
1 May 2012
K. H D. W R. R G. B
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Introduction. The articulating surfaces of a new metal-on-metal (MoM) hip prosthesis system were modified with the ceramic Titanium-Niobium-Nitride (TiNbN) by Physical Vapor Deposition (PVD). The purpose of the study was to investigate whether the elevation of the ion levels of chromium and cobalt, normally seen in the blood of patients after MoM hip arthroplasty, can be prevented by ceramic engineering of the articulating metal surfaces. Materials and methods. the ACCIS components (manufactured by Implantcast GmbH, Buxtehude, Germany from casted hi-carbon Co-Cr-Mo alloy) are heat treated, polished and micro-surface finished. Then TiNbN ceramic is integrated into the metal surfaces by PVD. 200 ACCIS resurfacing hip prostheses were implanted in three centres: Morriston Hospital, Swansea and Neville Hall Hospital, Abergavenny in the UK and Arthro Clinic, Hamburg, Germany. Blood samples of 60 randomly selected patients were analysed before surgery and at intervals of 3, 6, 12 and 24 months after surgery. Independent trace metal measurements were performed at the Universitätsklinikum Carl Gustav Carus Dresden, Germany. Results. the median chromium concentrations after 2 years were 0.94 (0.25-3.6) and the median cobalt concentrations after 2 years were 1.04 (0.07-2.36) μ gr/L. The average chromium concentration after 2 years was 1.073 and the average cobalt concentration after 2 years was 1.095 μ gr/L. None of the patients at any moment after operation showed an obvious increase of Cr and Co ions in the blood. Metal ion levels above the normal limits as described in the “Hand book for environmental medicine” were not seen (1). Conclusion. surface engineering of metal articulating surfaces effectively minimises corrosion and metal ion release


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 59 - 59
1 May 2016
Mount L Su S Su E
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Introduction. Patients presenting with osteoarthritis as late sequelae following pediatric hip trauma have few options aside from standard Total Hip Replacement (THR). For younger more active patients, Hip Resurfacing Arthroplasty (HRA) can be offered as an alternative. HRA has been performed in the United States over the past decade and allows increased bone preservation, decreased hip dislocation rates versus THR, and potential to return to full activities. Patients presenting with end-stage hip arthritis as following prior pediatric trauma or disease often have altered hip morphology making HRA more complicated. Often Legg-Calve-Perthes (LCP) patients present with short, wide femoral necks, and femoral head distortion including coxa magna or coxa plana. There often can be acetabular dysplasia in conjunction with the proximal femoral abnormalities. Slipped Capital Femoral Epiphysis (SCFE) patients have an alteration of the femoral neck and head alignment, which can make reshaping the femoral head difficult. In particular, the femoral head is rotated medially and posteriorly, reducing the anterior and lateral offset. We present a cohort of 20 patients, with history of a childhood hip disorder (SCFE or LCP), who underwent HRA to treat end-stage arthritis. Fifty percent had prior pediatric surgical intervention at an average age of 11. Method. After Institutional Review Board approval, data was reviewed retrospectively on patients with pediatric hip diseases of SCFE and LCP who underwent HRA using the Birmingham Hip Resurfacing (BHR) by a single orthopaedic surgeon at a teaching institution. Harris Hip Scores (HHS), plain radiographs and blood metal ion levels were reviewed at routine intervals (12 months and annually thereafter). Those who had not returned for recent follow-up were contacted via telephone survey for a modified HHS. Results. Twenty patients had mean follow up of 2.8 years (range 1–7 years). Twelve had LCP and 8 SCFE. Median implant duration was 2.4 years. One-year metal ion testing revealed median chromium level of 2.3 ppb and median Cobalt level of 1.5 ppb. At one-year follow up, plain radiographs demonstrated all patient implants to be well-fixed, without radiolucent lines or osteolysis. Two patients at three and five-year follow-up exhibited heterotopic ossification. Mean HHS for LCP at 6 weeks post-operative was 88, and 98 at one year. Mean HHS for SCFE at 6 weeks post-operative was 77.5, and 98.6 at one year. LLD was significantly improved with an average pre-operative LLD of 12.6 mm and post op of 2.6 mm (p-value <0.001). At most recent follow-up, all retained their implants with overall average HHS of 98. Conclusion. At minimum of one-year following HRA, an increase in functional outcomes is found in patients who underwent HRA for osteoarthritis associated with LCP and SCFE with a mean HHS of 98. No increase was found in complications including femoral neck fracture or implant loosening despite technical challenges of the procedure related to proximal femoral morphologic abnormalities, or presence of acetabular dysplasia [Fig 1]


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 38 - 38
1 Jan 2011
Langton D Jameson S Joyce T Webb J Nargol A
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This report documents the clinical and histological findings, the operative management and the explant analyses of patients with early aseptic failure of large metal-on-metal (MonM) bearing joints. Three hundred and fifty patients have been implanted with the ASR bearing surface (resurfacing or a modular THR) by a single surgeon at an independent centre since 2004. Six patients (all female) have been revised secondary to aseptic failure. All complained of severe groin pain exacerbated by straight leg raise and routine investigations were unable to establish a cause. Large amounts of sterile, highly viscous green fluid were aspirated from the hip joints in each case. Gross swelling of the pseudocapsule and a similar green fluid surrounding the implants were found at revision surgery. Histological examination of periprosthetic tissue samples showed changes consistent with ALVAL/metallosis, and analysis of the fluid revealed dense numbers of inflammatory cells. Symptoms in patients revised to ceramic-on-ceramic bearings improved post operatively. This was not the case with those reimplanted with MoM joints. Data from a subset of 76 patients (all unilateral resurfacings) showed that malaligned cups (anteverted > 20° +/− inclination angle > 45°) were associated with significantly higher whole blood metal ion levels than cups positioned within this range. All the patients with early aseptic failure had malaligned cups. Independent explant analysis revealed significant increases in the surface roughness values of the articular surfaces. Our results suggest that some patients develop a significant inflammatory reaction to metal implants. This may be due to high levels of metal debris around the implant as a result of accelerated wear. Poor component alignment was found in all our patients with early aseptic failure


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 38 - 38
1 Jan 2011
Jameson S Langton D Joyce T Webb J Nargol A
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Metal ion concentrations following metal on metal hip resurfacing arthroplasty remain a concern. Variables associated with increased metal ion concentrations need to be established. This study provides metal ion data from a consecutive cohort of the first 76 patients implanted with a fourth generation hip resurfacing prosthesis. All patients agreed to post-operative blood metal ion sampling at a minimum of one year. Post-operative radiographic measurements of cup inclination and anteversion were obtained using the EBRA software. Mean whole blood chromium (Cr) and cobalt (Co) concentrations in patients receiving the smallest femoral implants (Ł51mm) were greater than in the patients implanted with the largest prostheses (ł53mm) by a factor of 3 and 9 respectively. Ion concentrations in the small femoral group were significantly related to acetabular inclination (R=0.439, P< 0.001 for Cr, R=0.372, P=0.004 for Co) and anteversion (R=0.330, P=0.010 for Cr, R=0.338, P=0.008 for Co). This relationship was not significant in the large implant group. Mean Cr and Co concentrations in patients with accurately orientated cups (inclination < 45°, anteversion < 20°) were 3.7μg/l and 1.8 μg/l respectively, compared to 9.1μg/l and 17.5μg/l in malaligned cups. A reduced surface contact area caused by cup malalignment may increase contact stresses, resulting in a high wear rate if fluid film lubrication is inadequate. Improved fluid film lubrication has previously been found in larger heads in vitro. Accurate acetabular component positioning is essential in order to reduce metal ion concentrations following hip resurfacing


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 5 - 5
1 Sep 2012
Smith J Railton P Kinniburgh D Faris P David L Marshall D Burkart B Powell J
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In a cross sectional cohort study three different metal on metal total hip systems were assessed. Two monoblock acetabular designs; the Durom socket (Zimmer, Warsaw, In) and the Birmingham socket (Smith and Nephew, Memphis, TN), and one modular metal on metal total hip system (Pinnacle, Depuy Orthopaedics, Warsaw, In) in patients who have received these implants in the our region. 56 patients were recruited in total. All patients were assessed clinically, radiologically and biochemically. Whole blood Cobalt, Chromium and titanium levels were tested. The median head size used in the Birmingham group was 52mm (Range 44mm to 56mm), and in the Durom group, 48mm (Range 42 to 54mm). The median head size used in the modular Pinnacle group was 40mm (Range 36–44mm). The blood metal ions levels in the larger non modular acetabular sockets were significantly raised compared to the Pinnacle group. For Co 1.95 µg/l and 2.70 µg/l in the Durom and Birmingham groups respectively compared to only 0.52 µg/l in the Pinnacle group (P< 0.001). Mean Cr levels were the same for the two monoblock systems, 1.9 µg/l compared to the Pinnacle sockets 1.2 µg/l (P< 0.001). Our study clearly demonstrates that there is a significant difference in metal ion levels in patients following a monobloc large head arthroplasty system compared to a smaller modular metal on metal hip arthroplasty. The smaller head size appears to produce less metal ions whilst at the same time a 36mm–44mm head size is large enough to increase hip stability and range of movement as well as decreasing the risk of impingement. In our practice we are no longer using this design and the safest strategy, when considering metal on metal bearings, is to use a modular, smaller head system such as the Pinnacle


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 132 - 133
1 Mar 2009
Hart A Tarrassoli P Patel C Buddhdev P Hester T Muirhead-Allwood S Skinner J
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Introduction: We have previously shown an association between whole blood metal particles from unilateral metal on metal (MOM) hip resurfacing and reduced CD8+ T cells (JBJS Br April 2006). There are no reported clinical effects of these findings. Certain patients maybe at high risk of developing clinical effects; one such group is patients with bilateral hip resurfacings. There are no published studies of bilateral hip resurfacings. Our aim was to investigate the association between whole blood metal ions and reduced CD8+ T cells in a follow up cohort of bilateral MOM hip resurfacings. Method : Peripheral blood samples were analysed from patients with bilateral MOM hip resurfacings (n=25), unilateral hip resurfacings (n=34) and metal on polyethylene (MOP) hip arthroplasty (n=34). Samples were analysed for: lymphocyte subsets (FACS analysis); whole blood cobalt and chromium ion levels (using inductively-coupled mass spectrometry). Xrays revealed all hip components were well fixed. Results : When compared to patients with standard MOP hip replacements there was a 30% reduction in both the bilateral and unilateral resurfacing groups’ level of CD8+ cells (T cytotoxic) (p=0.010). All other lymphocyte subgroups were not significantly different. There was evidence of a threshold effect of raised metal ions and reduced CD8+ T cells but no evidence of a dose-response relationship. Conclusions : Bilateral MOM hip resurfacing is associated with a reduced CD8+ T cell count when compared to MOP hip arthroplasty. This association is not significantly different from the levels seen after unilateral MOM hip resurfacing


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 5 - 5
1 Aug 2012
Dhinsa B Perera J Gallagher K Spiegelberg B Hanna S Tai S Pollock R Carrington R Cannon S Briggs T
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The aim of this study is to investigate whether MoM implants result in more chromosome aberrations and increased blood metal ions postoperatively whe compared to MoP implants. MoM arthroplasties are being inserted in increasing numbers of younger patients due to the increased durability and reduced requirements for revision in these implants. Recent studies have raised many concerns over possible genotoxicity of MoM implants. This is a prospective study of patients who have undergone elective total hip replacement, they were selected and then randomised into two groups. Group A received a MoP implant and group B received a MoM implant. Patients are reviewed pre-operatively (control group), at 3 months, 6 months, 1 year and 2 years post-operatively. On each occasion blood tests are taken to quantify metal ion levels (chromium, cobalt, titanium, nickel and vanadium) using HR-ICPMS method and chromosome aberrations in T lymphocytes using 24 colour fluorescent in situ hydridisation (FISH). 51 patients have been recruited to date, 23 of whom had MoP prosthesis and 28 a MoM. 47 of these had their 1 year follow-up with blood analysis and 38 have had 2 year follow up. There appeared to be a bedding period for both MoM and MoP groups, with an increase in metal ion release. The blood concentration of chromium, cobalt and titanium rise significantly in the MoM group at the 2 year stage. Chromosome aberrations occurred in both groups. Both the MoM and MoP groups showed increase frequency of aneuploidy aberrations and structural damage. The greatest increase in metal ion levels occurred at the 1 to 2 year interval corresponding to significant rise in chromosome aberrations. Preliminary results of this study show that the levels of chromium, cobalt and titanium are significantly higher in the MoM group compared to the MoP group. This corresponds to increases in chromosome aberrations in the groups with increases in structural chromosome damage after two years


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 152 - 152
1 Mar 2013
Vijaysegaran P Banic G Whitehouse S Crawford R
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There has been much discussion and controversy in the media recently regarding metal toxicity following large head metal on metal (MoM) total hip replacement (THR). Patients have been reported as having hugely elevated levels of metal ions with, at times, devastating systemic, neurolgical and/or orthopaedic sequelae. However, no direct correlation between metal ion level and severity of metallosis has yet been defined. Normative levels of metal ions in well functioning, non Cobalt-Chrome hips have also not been defined to date. The Exeter total hip replacement contains no Cobalt-Chrome (Co-Cr) as it is made entirely from stainless steel. However, small levels of these metals may be present in the modular head of the prosthesis, and their effect on metal ion levels in the well functioning patient has not been investigated. We proposed to define the “normal” levels of metal ions detected by blood test in 20 well functioning patients at a minimum 1 year post primary Exeter total hip replacement, where the patient had had only one joint replaced. Presently, accepted normal levels of blood Chromium are 10–100 nmol/L and plasma Cobalt are 0–20 nmol/L. The UK Modern Humanities Research Association (MHRA) has suggested that levels of either Cobalt or Chromium above 7 ppb (equivalent to 135 nmol/L for Chromium and 120 nmol/L for Cobalt) may be significant. Below this level it is indicated that significant soft tissue reaction and tissue damage is less likely and the risk of implant failure is reduced. Hips were a mixture of cemented and hybrid procedures performed by two experienced orthopaedic consultants. Seventy percent were female, with a mixture of head sizes used. In our cohort, there were no cases where the blood Chromium levels were above the normal range, and in more than 70% of cases, levels were below recordable levels. There were also no cases of elevated plasma Cobalt levels, and in 35% of cases, levels were negligible. We conclude that the implantation with an Exeter total hip replacement does not lead to elevation of blood metal ion levels


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 100 - 100
1 Mar 2013
Kohan L Field C Kerr D
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Comparisons of blood metal ion levels of cobalt and chromium (CoCr) between metal-on-metal total and resurfacing hip arthroplasties are limited. High levels of CoCr may result in long-term adverse biological effects. We compare metal ions levels between total and resurfacing implants. 70 patients (28 males and 42 females) had a total hip arthroplasty using the Birmingham (Smith & Nephew) modular femoral component and a variety of stems, articulating with the Birmingham resurfacing component. The average age was 65.5 (±6.8) years and an average follow-up of 6.0 (±2.2) years. 170 patients (145 male and 25 female had a Birmingham resurfacing arthroplasty with an average age of 54.7 (±9.9) years and an average follow-up of 5.9 (±3.0) years. CoCr levels were measured. Bivariate correlations and independent samples t-tests were applied to determine similarities and differences within and between groups. Average ion levels in total arthroplasty patients were: Co 114.17 (±94.01) nmol/L (range 2–414); and Cr 75.12 (±68.45) nmol/L (range 10–312). Average levels in hip resurfacing arthroplasty were: Co 55.98 (±79.5) nmol/L (range 7–505); and Cr 70.77 (±87.41) nmol/L (range 5–751). Both total and resurfacing groups showed significant correlations (p<0.01) between Co and Cr levels. A significant difference was observed between the total and resurfacing group Co levels (p<0.0001). No significant difference was shown between group Cr levels (p>0.672). The average total hip replacement CoCr levels were higher than the hip resurfacing levels. While the overall activity level may be higher in the resurfacing group, possibly the incidence of stop/start frequency may be higher in the total hip replacement group. Hip resurfacing arthroplasty average CoCr levels are lower than those of total hip replacement patients. Associations between Co and Cr metal ion levels are shown within each group. Co levels differ significantly between groups where Cr does not. Long-term follow-up of CoCr levels are required


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 45 - 45
1 Jun 2012
Dhinsa B Gallagher K Nawaz Z Spiegelberg B Hanna S Tai S Pollock R Carrington R Cannon S Briggs T
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The aim of this study is to investigate whether Metal-on-Metal (MoM) implants result in more chromosome aberrations and increased blood metal ions post-operatively when compared to Metal-on-Polyethylene (MoP) implants. Metal-on-metal arthroplasties are being inserted in increasing numbers of younger patients due to the increased durability and reduced requirement for revision in these implants. Recent studies have raised many concerns over possible genotoxicity of MoM implants. This is a prospective study of patients who have undergone elective total hip replacement, they were selected and then randomised into two groups. Group A received a MoP implant and group B received a MoM implant. Patients are reviewed pre-operatively (control group), at 3 months, 6 months, 1 year and 2 years post-operatively. On each occasion blood tests are taken to quantify metal ion levels (chromium, cobalt, titanium, nickel and vanadium) using HR-ICPMS method and chromosome aberrations in T lymphocytes using 24 colour fluorescent in situ hybridisation (FISH). 53 patients have been recruited to date. 24 of whom had MoP prosthesis and 29 a MoM. 37 of these have had their one year follow-up with blood analysis and 14 have had 2 year follow up. Cobalt and chromium concentration increased during the first 6 months in both MoM and MoP groups, in the MoM group the chromium levels were twice that of MoP group and 12x that of the preoperative samples. Chromosome aberrations occurred in both groups. At 6 months both the MoM and MoP groups showed increase frequency of aneuploidy aberrations with further increases after one year. Structural damage in the form of translocations occurred in the MoM group after one year, but not in the MoP group, by two years there was a profound increase in translocations Preliminary results of this study show that the levels of chromium and cobalt are significantly higher in the MoM group compared to the MoP group. This corresponds to increases in chromosome aberrations in the groups with increases in structural chromosome damage after two years


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 28 - 28
1 Jan 2013
Langton D Sidaginamale R Lord J Joyce T Natu S Nargol A
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Background. Previous studies have suggested that the modular junction of metal on metal (MoM) total hip replacements (THR) is an important source of metallic debris. Methods. We carried out a prospective study using custom techniques to analyse one of the largest collections of failed contemporary MoM devices in the world. All explants from patients who had suffered adverse reactions to metal debris (ARMD) were included in this study. These explants included: 82 36mm THRs, and 147 resurfacing head THRs and 140 resurfacing arthroplasties from several manufactures. Volumetric wear analysis of the bearing surfaces and taper junctions was carried out using a coordinate measuring machine. The relationships between total metallic loss and metal ion concentrations and the macroscopic and histological tissue appearance of THR patients were compared to those in resurfacing patients. Mann Whitney test for non-parametric data was used to assess significant differences between groups. Results. Resurfacing explants retrieved from patients who had suffered ARMD were found to have significantly higher median rates of volumetric wear than the THRs (10.16 versus 2.25mm. 3. /yr (p < 0.001)). Total volumetric material loss from taper junctions ranged from 0.01 to 21.55mm. 3. When volumetric taper wear was combined with bearing surface wear in the THR patients this total rate of material loss was still significantly less than in the resurfacing patients 2.52 versus 10.16mm. 3. /yr (p < 0.001)). Despite this, macroscopic tissue destruction and extent of ALVAL infiltration was found to be significantly greater in the THR patients. Conclusion. Taper debris appears to more readily stimulate a destructive immune cascade than debris from primary bearing surfaces. This cascade can culminate in catastrophic tissue necrosis when blood metal ion concentrations appear normal. MHRA guidance should distinguish clearly between MOM THRs and resurfacings


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 184 - 184
1 Mar 2008
Sessa V Rossetti S
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Since wear debris is recognised as a major cause of hip prosthesis loosening in the last decade, research was aimed to lower the coefficient of friction. Polyethylene revealed to be the principal source of debris so new bearing materials were introduced in the effort to increase implant longevity. In 1965 Mc Keee Farrar introduced metal on metal bearings, in 1970 Boutin ceramic on ceramic. Both of them demonstrated the capability to reduce wear debris more than 97% as compared to PE-metal coupling but have possible risks. Ceramic heads are scratch resistant but they can fracture, then they offer limited options as lenght and diameter. Metal on metal bearing couples give all the options but can determine high blood metal ions level, potentially dangerous. To avoid these risks new coupling materials were introduced: oxinium and cross-linked polyethylene. Cross-linked ultra-high molecular weight polyethylene was first employed for liners more than 30 years ago with excellent results. On the other hand oxinium is a metal compound of 97,5% zirconium and 2,5% niobium, whose surface is transformed into a smooth ceramic with a coefficient of friction that is half that of cobalt-chrome, and same wettability and hardness of ceramic. Oxinium-cross-linked polyethylene produce nearly undetectable wear even if subjected to abrasive conditions. Oxinium femoral heads offer the option of different neck lenght and head diameter. Laboratory testing demonstrated that rough oxinium heads provided 61% less polyethylene wear than did the rough metal heads. Clinical results have a too short follow-up to be reported but are promising


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 81 - 81
1 Jan 2011
Spiegelberg BGI Hanna SA Tai S Gokaraju K Carrington R Pollock R Cannon SR Briggs TWR
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Introduction: The aim of this study is to investigate whether MoM implants result in more chromosome aberrations and increased blood metal ions post-operatively when compared to MoP implants. Large head metal-on-metal articulating surfaces of the hip are being used in increasing numbers of patients for oncological purposes due to the increased stability and reduced dislocation rate. Recent studies have raised many concerns over possible genotoxicity of MoM implants. Methods: This is a prospective study of patients who have undergone elective total hip replacement. Patients were randomised into two groups (MoP and MoM). Patients are reviewed pre-operatively (control group), at 3 months, 6 months, 1 year and 2 years post-operatively. On each occasion blood tests are taken to quantify metal ion levels (chromium, cobalt, titanium, nickel and vanadium) using HR-ICPMS and chromosome aberrations in T lymphocytes using 24 colour fluorescent in situ hybridisation (FISH). Results: 24 patients had MoP prosthesis and 29 a MoM. Cobalt and chromium concentration increased during the first 6 months in both MoM and MoP groups, in the MoM group the chromium levels were twice that of MoP group and 12x that of the preoperative samples. There was no difference with the levels of titanium, nickel and vanadium. Chromosome aberrations occurred in both groups. At 6 months both the MoM and MoP groups showed increase frequency of aneuploidy aberrations with further increases after one year. Structural damage in the form of translocations occurred in the MoM group after one year, but not in the MoP group. Discussion: Results of this study show that the levels of chromium and cobalt are significantly higher in the MoM group compared to the MoP group. This corresponds to increases in chromosome aberrations between the groups particularly in aneuploidy and translocations present in the MoM group at 1 year


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 131 - 131
1 Mar 2009
Hart A Tarassoli P Patel C Powell J Fersht N Muirhead-Allwood S Skinner J
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Introduction and aim: We have previously shown an association between whole blood metal ions and reduced CD8+ T cells in patients with unilateral metal on metal (MOM) hip resurfacings. Our aim was to substantiate this controversial finding with a follow up cohort of larger numbers of patients before further immunological investigation. Method: We measured lymphocyte subset counts and whole blood Cobalt and Chromium in 2 groups of patients: a Birmingham hip resurfacing group (n=100); and a metal on polyethylene MOP hip arthroplasty group (n=34). Metal ions were measured using inductively-coupled mass spectrometry (ICP-MS) with a Dynamic Reaction Cell (DRC). The detection limit was 10 parts per trillion. All hip components were well fixed, clinically and radiologically. Results: Cobalt and chromium levels were significantly elevated in the MOM resurfacing group compared to the MOP group (p< 0.0001). There was a statistically significant decrease in the MOM resurfacing groups’ level of CD8+cells (T cytotoxic) (p=0.005) when analysed by a Mann-Whitney U test. There was no significant difference between levels of CD4+ (T helper cells), CD19+ (B cells) and CD16/56+ (Natural Killer cells). A threshold level of blood cobalt and chromium ions for depression of total numbers CD8+ T cells was observed. Conclusions: This follow up cohort of 100 MOM hip resurfacing patients has replicated the association of reduced CD8+ T cells and raised metal ion levels observed in our founder cohort. This was specific to CD8+ T cells. We are now more certain that this association needs further detailed immunological investigation


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 133 - 133
1 Mar 2008
Vendittoli P Roy A Mottard S Lavigne M
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Purpose: Tribological studies suggest that larger metal-on-metal articulations would produce less wear than smaller diameter components. The aim of the present study is to describe whole blood Chrome and Cobalt ions concentration after metal-metal total hip arthroplasty (THA) and surface replacement arthroplasty (SRA). Methods: 180 patients eligible for the study were randomized to receive uncemented 28 mm metal-metal THA or a hybrid metal-metal SRA. Whole blood samples were collected pre-operatively, at three, six months and one year post operatively. Chrome and Cobalt concentration were measured by mass spectrophotometry. Results: At one year post op, whole blood levels of the were Cr 1.8 umol/L and Co 0.6 umol/L for the SRA and Cr 1.7 umol/L and Co 0.8 umol/L for the THA group (Cr, p=0.676 and Co, p=0.08). In comparison to pre-operative levels, the post operative levels significantly incresed for all elements Cr 1.9x and Co 3.8x for the SRA; Cr 1.3x and Co 3.4x. for the SRA group, Anova regression tests showed a significant relation between component size and Cr and Co metal ions levels; the larger the component, the lower the ions levels (Cr p=0.0285 and Co p=0.0442). Conclusions: Using these specific implants, the increases whole blood metal ions were similar to the best results found in the literature for 28 mm metal-metal THA. Results of this study confirm the good tribologic performances of the Metasul large diameter metal-metal articulations. Funding: Commerical funding Funding Parties: Zimmer


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 91 - 91
1 Aug 2012
Joyce T Lord J Langton D Nargol A
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Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent introduction. As such, survivorship rates from independent centres alongside explant analysis are rare. The early experience with this novel ceramic-on-metal (CoM) bearing couple is reported. Methods and Materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine. The roughness of the articulating surfaces was measured with a non-contact profilometer. Results. In 54 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34-87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm3 respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The very high early failure rate using COM is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons need to be aware of this new mechanism of failure which is associated with low metal ions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVI | Pages 13 - 13
1 Apr 2012
Mangat N Langton D Joyce T Jameson S De Smet K Nargol A
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Bearing diameter and acetabular component orientation have been shown to be important variables effecting blood metal ion levels following hip resurfacing arthroplasty. So far no studies on bilateral hip resurfacings have taken into account these variables. We examined the serum ion results of patients under the care of two experienced hip resurfacing surgeons who carry out ion analysis as part of routine post operative care. Surgeon 1: Patients were implanted exclusively with a “third generation” resurfacing device. Surgeon 2: Patients were implanted with the same “third generation” device and also a low clearance “fourth generation” resurfacing device. Only ion results from patients who were 12 months post surgery were included. Bilateral patients were matched to unilateral patients according to the surgeon performing the operation; the resurfacing system implanted and cup inclination and anteversion angles. The ion data from each bilateral group was tested against the corresponding unilateral groups using the Mann Whitney U test for non parametric data. Significance was drawn at p<0.05. Surgeon 1: There were 310 patients with unilateral joints and 50 with bilateral joints. There were no significant differences with regard to time to follow up, activity levels, joint sizes or cup orientations. Serum chromium (Cr) and cobalt (Co) concentrations were significantly greater in the bilateral group (p<0.001). Median ion levels were greater in the bilateral group by a factor of >2 in the smallest joint sizes and <2 in the largest joints. Surgeon 2: There were 11 patients with bilateral third generation resurfacing joints and 50 with unilateral joints of the same design. The same relationship as described above was identified. There was a notable difference in the fourth generation implant group (n=13 bilateral, n=100 unilateral). Median ion levels for patients receiving bilateral joints of sizes <47mm were ten times greater than in the corresponding unilateral group. Bearing diameter and component design are critical factors in determining metal ion levels following bilateral hip resurfacings. Surgeons must consider the potential implications of gross increases in metal ion levels prior to performing bilateral hip resurfacings in smaller patients


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 223 - 223
1 May 2011
Vendittoli PA Amzica T Roy A Girard J Laffosse J Lavigne M
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Introduction: Metal on metal hip replacement using large diameter bearings can be used as part of a hip resurfacing (HR) system or with a large diameter head total hip arthroplasty (LDH-THA). Both types of implant release metal ion, but the amount of ion released after LDH-THA has not been studied. The aim of the present study was to assess whole blood metal ion release at one year following LDH-THA. Material and Method: Pre and post operative Cr, Co and Ti concentrations in whole blood were measured using a high resolution mass spectrometer (HR-ICP-MS) in 29 patients with LDH-THA (Durom LDH, Zimmer). The results were compared to published ion levels on a HR system (Durom, Zimmer) possessing the same tribological characteristics, the only differences being the presence of a modular sleeve and opened femoral head design in LDH-THA. Summary of results: Post operative Cr, Co and Ti mean levels of LDH-THA were 1.3, 2.0 and 2.8 μg/L at 6 months and 1.3, 2.2 and 2.7 μg/L at 12 months. In the LDH-THA, the opened femoral head design showed significantly higher Co ion concentrations than the closed femoral head design (3.0 vs 1.8 ug/L, p=0.037). Compared to previously published results after HR, Co levels were significantly higher at one year in the LDH THA (2.2 ug/L vs. 0.7 ug/L, p< 0.001). Discussion: In order to reduce wear and ion release from metal-metal bearing, most manufacturers focus research on improvements at the bearing surfaces. This study has demonstrated that the addition of a sleeve with modular junctions and an open femoral head design of LDH-THA causes more Co release than bearing surface wear (157% and 67% respectively). Even if no pathological metal ion threshold level has been determined, efforts should be made to minimize their release. We recommend modification or abandonment of the modular junction and femoral head closed design for this specific LDH-THA system. The total amount of ion released from a metal-metal implant should be considered globally and newer implant design should be scientifically evaluated before their widespread clinical use


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 82 - 82
1 Sep 2012
Joyce T Lord J Nargol A Langton D
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Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent innovation. As such, survivorship rates from independent centres alongside explant analysis are rare. The early clinical experience with this novel ceramic-on-metal (CoM) bearing couple is reported alongside explant analysis of failed devices. Methods and materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine (Mitutoyo Legex 322, manufacturer's claimed accuracy 0.8µm). The roughness of the articulating surfaces of heads and liners was measured with a non-contact profilometer (ZYGO NewView 5000, 1nm resolution). Results. In 56 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34–87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm. 3. respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The high early failure rate using a COM articulation is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons and bioengineers need to be aware of this new mechanism of failure in this novel biomaterial coupling which is associated with low metal ions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 157 - 157
1 Sep 2012
Lee D Powell J Burkart B Smith J Kinniburgh D Faris P Parker R Marshall D Railton P
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Purpose. To determine whether there is a difference in the metal ion levels among three different metal-on-metal total hip systems: two monoblock large heads and one modular metal-on-metal total hip replacement system in patients who received these implants in our region. Method. A group of 56 patients were recruited that had either undergone total hip replacement (THR) with a Birmingham resurfacing socket, the Durom resurfacing socket, or a Pinnacle metal-on-metal bearing surface. All patients recruited were at least one year following their surgery in order that their ion levels had reached a steady state. We reviewed every patient clinically, radiographically as well as biochemically. Blood was obtained for cobalt (Co) and chromium (Cr) levels. Current radiographs were arranged to assess the stability and mechanics of the total hip systems. All patients signed an informed consent and completed three questionnaires, The Western Ontario and McMaster Universities (WOMAC) index, the Short Form 36 (SF36) and UCLA activity score. A Harris Hip score was completed in order to assess individual hip function. Statistical analysis was performed on the collected data to assess whether there were any other potential influence on the mean levels of Co and Cr. Results. The blood metal ion levels in the larger non modular acetabular sockets were significantly raised compared to the Pinnacle group. For Co, 1.95 parts per billion (ppb) and 2.70 ppb in the Durom and Birmingham groups respectively compared to only 0.52 ppb in the Pinnacle group (P< 0.001). Cr levels were the same in the two monoblock systems, 1.9 ppb compared to the Pinnacle sockets 1.2 ppb (P<0.001). In all groups however these levels were within an acceptable safe range. The mean head size used in the Birmingham group was 53.2mm (Range 44mm to 56mm), and in the Durom group, 47.1 (Range 42 to 54mm). The mean head size used in the modular group was 37.3mm (Range 36–44mm). There was no difference between the three groups in terms of functional outcome and patient demographics were similar in all three groups. There was no statistical difference between the groups in terms of anteversion and abduction angles. There was also a smaller spread in this group in terms of range of angles. There was also no relationship between these values and the metal ion levels. Conclusion. All three total hip systems demonstrated average metal ion whole blood levels in a safe range. Larger diameter metal on metal bearings had higher ion levels


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 34 - 34
1 Aug 2013
Chu J Easteal R John PS Kunz M Rudan J
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Metal-on-metal hip resurfacing arthroplasty (MoMHRA) has been a popular alternative treatment for young patients with hip osteoarthritis. Despite its advantages over total hip arthroplasty, the use of MoMHRA remains controversial. Achieving the correct positioning of the prosthetic is a concern due to the difficulty and novelty of this procedure. Furthermore, it has been reported that post-operative management using 2D radiographs contains high degrees of variance leading to poor detection of prosthetic malpositioning. In order to compensate for the lack of available technology, current literature has suggested the use of blood metal ion levels as indirect predictors of prosthetic malpositioning due to the abnormal release of metal ions, particularly Chromium and Cobalt, as a result of increase wear and tear. The purpose of this study was to determine whether 2D/3D registration technology can report prosthetic orientation in vivo and, to establish whether 3D technology can accurately deduce prosthetic wear by correlating prosthetic angles with metal ion counts. To begin this study, post-operative x-rays (n=72) were used as the two-dimensional media to measure acetabular orientation. Only the acetabular component was examined in this study and acetabular orientation was defined as the function of inclination and version angles. Virtual three-dimensional models of the native, pre-operative pelvises and the acetabular implant were generated and were manually superimposed over the post-operative x-ray images according to anatomical landmarks. A manual 2D/3D registration program was specifically designed for this task. Inclination and version angles of the 2D/3D registered product were measured. Post-operative CT models, which offer the most accurate depiction of the prosthetic in vivo, were generated for validation. Contrary to the study's hypotheses and current literature, no significant difference was observed between 2D vs. 2D/3D vs. CT data, suggesting that 2D and 2D/3D measurements were similar to the results of the gold standard CT model (although 2D/3D measurements were more precise compared to 2D media). Furthermore, statistical analyses revealed no significant correlation in either 2D or 2D/3D compared to metal ion levels, although a stronger trend was demonstrated using 2D/3D measurements. These results are suggestive that 2D/3D registered measurements are equivocal to those using the conventional 2D x-ray and, manual 2D/3D registered measurements do not demonstrate greater efficacy in predicting prosthetic wear. Moreover, the data from this study also revealed insignificant correlations between the angles of acetabular orientation and metal ion release. Combined angles within and beyond the acceptable ranges for inclination (30°–50°) and version (5°–20°) angles did not produce significant trends with metal ion release. These results lead to the paradoxical conclusion that acetabular orientation does not influence prosthetic wear. The findings of this study are inconsistent with the reports in current literature and further investigation is required