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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


The Bone & Joint Journal
Vol. 98-B, Issue 1 | Pages 33 - 39
1 Jan 2016
Sabah SA Henckel J Koutsouris S Rajani R Hothi H Skinner JA Hart AJ

Aims. The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. . Methods. We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. Results. We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. Discussion. This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. Take home message: Prospective Registry – retrieval linkage is a simple tool to evaluate and improve data quality on the NJR. Cite this article: Bone Joint J 2016;98-B:33–9


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 26 - 26
1 Nov 2015
Skinner J Sabah S Henckel J Cook E Hothi H Hart A
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Introduction. The National Joint Registry (NJR) for England, Wales and Northern Ireland contributes important information on the performance of implants and surgeons. However, the quality of this data is not known. This study aimed to perform an independent validation of primary metal-on-metal hip procedures recorded on the NJR through linkage to the London Implant Retrieval Centre (LIRC). Patients/Materials & Methods. Primary, metal-on-metal hip arthroplasties performed between 1st April 2003 and 5th November 2013 were recruited from the NJR (n=67045). Retrieved, metal-on-metal components were recruited from the LIRC (n=782). Data linkage and validation checks were performed. Results. 476 procedures (60.9%) on the LIRC were successfully linked to the NJR. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Discussion. Registry-Retrieval linkage provided a novel means for data validation, particularly for component fields. This study suggests that NJR reports may underestimate revision rates for many types of metal-on-metal hip. This is topical given the increasing scope for NJR data. We recommend a system for continuous, independent evaluation of NJR data quality and validity


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 414 - 414
1 Oct 2006
Steffen R Smith S Gill H Beard D McLardy-Smith P Urban J Murray D
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Purpose This study aims to investigate blood flow in the femoral head during Metal-on-Metal Hip Resurfacing (MMHR) through the posterior approach by monitoring oxygen concentration during the operative procedure. Methods Following division of fascia lata, a calibrated gas-measuring electrode was inserted into the femoral neck, aiming for the anterolateral quadrant of the head. Baseline oxygen concentration levels were detected after electrode insertion 2–3cm below the femoral head surface and all intra-operative measures were referenced against these. Oxygen levels were continuously monitored throughout the operation. Results of measurements from ten patients are presented. Results Oxygen concentration was reduced during the surgical approach and average oxygen concentration following dislocation and circumferential capsulotomy dropped to 43% of baseline (Std.dev +/−37%), this was a highly significant reduction (p< 0.005). Insertion of implants resulted in a further significant drop in oxygen concentration (p< 0.02) to 16% of baseline (Std. dev +/−27%). Oxygen concentration rose slightly after relocation of the resurfaced joint and reconstruction of posterior soft tissues, reaching 22% (Std.dev +/−31%) of initial baseline oxygen levels. Considerable variation between subjects was observed. Three subjects had no remaining oxygen concentration at the end of surgery. Conclusion Intra-operative measurement of oxygen concentration in blood perfusing the femoral head is feasible. During MMHR there is a dramatic decrease in femoral oxygenation during surgical approach and implant fixation. This may increase the risk of avascular necrosis and subsequent femoral neck fracture. Future experiments will determine if less invasive procedures or a different approach can protect the blood supply to femoral neck and head


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_II | Pages 13 - 13
1 Feb 2012
Steffen R Smith S Gill H Beard D McLardy-Smith P Urban J Murray D
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This study aims to investigate femoral blood flow during Metal-on-Metal Hip Resurfacing (MMHR) by monitoring oxygen concentration during the operative procedure. Patients undergoing MMHR using the posterior approach were evaluated. Following division of fascia lata, a calibrated gas-measuring electrode was inserted into the femoral neck, aiming for the supero-lateral quadrant of the head. Baseline oxygen concentration levels were detected after electrode insertion 2-3cm below the femoral head surface and all intra-operative measures were referenced against these. Oxygen levels were continuously monitored throughout the operation. Data from ten patients are presented. Oxygen concentration dropped most noticeably during the surgical approach and was reduced by 62% (Std.dev +/-26%) following dislocation and capsulectomy. Insertion of implants resulted in a further oxygenation decrease by 18% (Std.dev +/-28%). The last obtained measure before wound closure detected 22% (Std.dev +/-31%) of initial baseline oxygen levels. Variation between subjects was observed and three patients demonstrated a limited recovery of oxygen levels during implant insertion and hip relocation. Intra-operative measurement of oxygen concentration in blood perfusing the femoral head is feasible. Results in ten patients undergoing MMHR showed a dramatic effect on the oxygenation in the femoral head during surgical approach and implant fixation. This may increase the risk of avascular necrosis and subsequent femoral neck fracture. Future experiments will determine if less invasive procedures or specific positioning of the limb can protect the blood supply to femoral neck and head


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 38 - 38
19 Aug 2024
Meek D
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In 1997 the Birmingham Hip Resurfacing was introduced to address the needs of young active patients. Alternative designs were introduced to try and improve wear performance. The aim of this study was a comparative cohort study of two types of metal-on-metal bearing to determine the mechanism of failure at 15 years.

The study reviewed 91 Brimingham Hip Resurfacings (BHR) (Smith and Nephew) and 715 DUROM hip resurfacing (Zimmer) procedures in prior to 2009. Failure was defined as revision of either component for any reason. Kaplan-Meyer survivorship analysis performed. Routine follow-up with serum metal ion levels and radiographs.

Mean follow-up was 17.9 years (range 15.2 – 25.1). The mean age at operation was 51.6 years (SD 8.6, range 20.7 to 70.2), including 299 women (37.1%). The Birmingham resurfacing demonstrated 92.3% survivorship at 15 years (SE 2.8, 95% CI 3.9 – 7.8) and 90.0% at latest follow-up (SE 3.5, 95% CI 4.9 to 9.4). By comparison, the DUROM survivorship at 15 years was 89.1% at 15 years (SE 1.2, 95% CI 2.0 to 2.5) and 87.4% (SE 1.3, 95% CI 2.5 to 2.3) at latest follow-up. There was no statistically significant difference in survivorship between groups (p= 0.32). Survival in male patients was 92.7% compared to 80.0% in females. The reported failures occurred from Adverse Reaction to Metal Debris (32 patients), periprosthetic femoral neck fracture (6) and aseptic loosening (41), PJI (12) and undiagnosed pain (6). The mean cobalt and chromium levels at last follow-up were 33.4 nmol/L and 36.5 nmol/L respectively.

This study demonstrates two differently designed metal-on-metal hip resurfacing provided a durable alternative to total hip replacement, particularly in younger male patients with osteoarthritis. Differences in design did determine the reason for revision with acetabular fixation being one of the principal failure mechanisms for the DUROM compared to elevated ion levels.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 31 - 31
23 Jun 2023
Meek D Jenkinson M Macmillan S Tate R Grant H Currie S
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Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l. Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. The extent of cardiovascular injury, measured by global longitudinal strain (GLS), in patients with elevated blood cobalt levels has not previously been examined.

Sixteen patients with prospectively collected blood cobalt ion levels above 13µg/l were identified and matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. Patients underwent echocardiogram assessment including GLS.

Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l compared to 0.01µg/l in the control group. There was no difference or correlation in EF, left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009).

For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 23 - 23
2 Jan 2024
Ciatti C Quattrini F Asti C Maniscalco P
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Previous scientific studies have highlighted how coupling is an important element affecting total hip arthroplasty's survival.

This study aims to evaluate whether metal-on-metal (MOM) coupling could be a statistically significant risk factor.

The data from the regional joint registry (Registro dell'Impiantologia Protesica Ortopedica, RIPO) was used for analysis. The data collection accuracy of this registry was 97.2% in 2017.

We retrospective evaluate all MOM total hip arthroplasties (THAs) implanted in our department between January 01st 2000 and December 31st 2011. We used a control group composed by all other prosthesis implanted in our Department in the same time lapse.

We registered 660 MOM THAs. Mean age of patients was 66.9 years. 603 patients have a >36mm head, while 78 a <36 mm one. Neck modularity was present in half of patients. 676 implants were cementless. We registered 69 revisions, especially due to aseptic mobilization (16 THAs), implant breakage (9 THAs) and periprosthetic fracture (6 THAs).

The MOM THAs overall Kaplan-Meier survival rate was 87.2 at 15 years, and the difference between MOM THAs and other implants two curves is statistically significant (p<0.05). Male sex is a significant risk factors. Further evaluations are in progress to establish the presence of any additional risk factors. We think weight and/or BMI may be included in this category.

Our study confirms the data currently present in the literature regarding a lower survival of metal-on-metal hip prostheses.

The male sex is a statistically significant risk factor (p<0.05), while age, head size and modularity of the prosthetic neck are not statistically significant (p>0.05).

Any new finds will be presented at the congress venue.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 9 - 9
7 Jun 2023
Jenkinson M Meek D MacMillan S Tate R Grant MH Currie S
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Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l (13ppb, 221nmol/l). Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. Global longitudinal strain (GLS) is an echocardiography measurement known to be more sensitive than ejection fraction at diagnosing early cardiomyopathies. The extent of cardiovascular injury, as measured by GLS, in patients with elevated blood cobalt levels has not previously been examined.

Sixteen patients with documented blood cobalt ion levels above 13µg/l were identified from a regional arthroplasty database. They were matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. All patients underwent electrocardiogram and echocardiogram assessment for signs of cardiomyopathy including GLS.

Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l (495nmol/l) compared to 0.01µg/l (0.2nmol/l) in the control group. There was no difference or correlation in ejection fraction (EF), left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009).

For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt above 13µg/l. Further work is recommended to assess if these cardiac changes are present in patients with elevated blood cobalt levels below 13µg/l.


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. 88-B, Issue SUPP_III | Pages 387 - 387
1 Oct 2006
Liu F Jin Z Rieker C Hirt F Roberts P Grigoris P
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Introduction: Hip simulator and clinical retrieval studies have shown that metal-on-metal (MOM) hip implants commonly have biphasic wear. An initial high wear or running-in phase is generally followed by a low wear or steady-state phase. A number of hypotheses have been put forward to explain this biphasic phenomenon, including polishing of the metallic bearing surfaces and increasing conformity between the two articulating surfaces. The purpose of the present study was to compare the wear and lubrication of MOM hip implants between the running-in and steady-state periods. Materials and Methods: A standard 28mm Metasul. TM. MOM bearing (Centerpulse Orthopedics, a Zimmer Company, Winterthur, Switzerland) was investigated. The wear testing was carried out using a 6-station AMTI hip simulator in the presence of 33% bovine serum and 67% Ringer solution (PH 7.2). The bearing surfaces of both the femoral and acetabular components were measured using a coordinate measurement machine at different stages of wear testing. The dimensional changes of the bearing surfaces due to wear were directly incorporated into the elastohydrodynamic lubrication analysis using an in-house developed code. Results: The initial running-in period occurred during the first 1 million cycles, and little wear was observed subsequently up to 5 millions cycles. The maximum total wear depth was measured to be around 13 μm at 1 million cycles. The predicted average lubricant film thickness between the two articulating surfaces was increased from 0.024μm at the beginning, to 0.09μm at the end of the first 1 million cycles. For a given composite surface roughness of 0.03μm often quoted for the metallic bearing surfaces, such an increase in the lubricant film thickness represents a transition from a mixed to a fluid film lubrication regime. Discussion: A large improvement in lubrication was predicted as a direct result of the running-in wear of the bearing surfaces. This was mainly due to the increased conformity between the two articulating surfaces and the decreased diametrical clearance. It was particularly noted that the improvement in lubrication after 1 million cycles was so significant that continuous fluid film lubrication was possible, leading to extremely low wear for up to 5 million cycles, and only material fatigue and start-up and stopping for wear measurements could cause a further increase in wear. It is possible in theory to optimise the geometry of the metallic bearing surfaces, based on the worn components, to minimise the running-in wear. However, such an improvement in lubrication cannot be readily achieved because of difficulties in surgical techniques and position of the components


The Bone & Joint Journal
Vol. 96-B, Issue 11_Supple_A | Pages 17 - 21
1 Nov 2014
Dunbar MJ Prasad V Weerts B Richardson G

Metal-on-metal resurfacing of the hip (MoMHR) has enjoyed a resurgence in the last decade, but is now again in question as a routine option for osteoarthritis of the hip. Proponents of hip resurfacing suggest that its survival is superior to that of conventional hip replacement (THR), and that hip resurfacing is less invasive, is easier to revise than THR, and provides superior functional outcomes. Our argument serves to illustrate that none of these proposed advantages have been realised and new and unanticipated serious complications, such as pseudotumors, have been associated with the procedure. As such, we feel that the routine use of MoMHR is not justified.

Cite this article: Bone Joint J 2014;96-B(11 Suppl A):17–21.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 62 - 62
1 Feb 2012
Dunstan E Ladon D Whittingham-Jones P Cannon S Briggs T Case P
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Purpose. Metal-on-Metal (MoM) hip bearings are being implanted in ever-increasing numbers and into ever-younger patients. The consequence of chronic exposure to metal ions is a cause for concern. Therefore, using cytogenetic biomarkers, we investigated a group of patients who have had MoM bearings in situ for in excess of 30 years. Method. Whole blood specimens were obtained from an historical group of patients who have had MoM bearings in situ for in excess of 30 years. Blood was also obtained from an age and sex matched control group and from patients with Metal-on-Polyethylene (MoP) components of the same era. The whole blood was cultured with Pb-Max karyotyping medium and harvested for cytogenetics after 72 hrs. The 24 colour FISH (Fluorescent In Situ Hybridisation) chromosome painting technique was performed on the freshly prepared slides, allowing chromosomal mapping. Each slide was evaluated for chromosomal aberrations (deletions, fragments and translocations) against the normal 46 (22 pairs and two sex) chromosomes. At least 20 metaphases per sample were scored and the number of aberrations per cell calculated. Results. Chromosomal aberrations, including deletions, fragments and translocations were only detected in the peripheral blood lymphocytes isolated from the group that had MoM bearings. These changes were not present in the age and sex matched control group. The chromosomal aberrations were also detected in the patients previously exposed to MoM bearings who have been revised to a MoP articulation. Conclusion. We have detected dramatic chromosomal aberrations in peripheral blood lymphocytes in a group of patients chronically exposed (over 30 years) to elevated metal ions. It is not known whether these aberrations have clinical consequences or whether they are reproduced in other cells in the body. The results emphasise the need for further investigations into the effect of chronic exposure to elevated metal ions produced by orthopaedic implants


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 33 - 33
2 May 2024
Dickenson E Griffin J Wall P McBryde C
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The 22 year survivorship of metal on metal hip resurfacing arthroplasty (RSA) is reported to be 94.3% with expert surgeons, in males with head sizes greater than 48mm. The 2023 National Joint Registry (NJR) report estimates survivorship of all RSA at 19 years to be 85%. This estimate includes all designs, head sizes and females. Our aim was to estimate the survivorship of RSA currently available for implantation (males only, head size >48mm, MatOrtho Adept or Smith and Nephew Birmingham Hip Resurfacing (BHR)) in those under 55 years, performed by all surgeons, compared to conventional THR.

We performed a retrospective analysis of the NJR. We included all males under 55 years who had undergone BHR or Adept RSA with head size greater than 48mm. Propensity score matching was used to produce two comparable groups of patients for RSA or conventional THR. We matched in a 3:1 ratio (THR:RSA) using sex, ASA, BMI group, age at primary procedure, surgeon volume, diagnosis and surgeon grade as covariates. The primary analysis was survivorship at 18 years. Time-to-revision was assessed using Kaplan-Meier curves. Cox's proportional hazard models were used to investigate between group differences.

4839 RSA were available for analysis. After matching the RSA and THR groups were well balanced in terms of covariates. Survivorship at 18 years was 93.7% (95% CI 89.9,96.2) in the RSA group and 93.9% (90.5,96.0) in the THR group. Despite these similar estimates the adjusted hazard ratio was 1.40 (95% CI 1.18, 1.67 p<0.001) in favour of THR.

Survivorship of the currently available RSA in males under 55 was 93.7% at 18 years, however THR survivorship was superior to RSA. These results, generalisable to UK practice, should be set against perceived benefits in functional status offered in RSA when counselling patients.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 31 - 31
1 Mar 2013
Amstutz HC Campbell P Dorey FJ Johnson A Skipor A Jacobs JJ
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The Conserve® Plus (Wright Medical Technology Inc., Arlington, TN) was introduced clinically in the United States in 1996. A study of the serum cobalt and chromium ion levels was started in 2000 in our center to monitor the metal ion levels over time as part of an FDA clinical trial. Thirteen male and five female patients received this resurfacing for idiopathic osteoarthritis (14), post-traumatic degenerative changes (3) or developmental dysplasia (1). Fourteen received a unilateral implant but four subsequently received a contralateral device from 52 to 86 months post-op. Four patients had bilateral resurfacings done in a one-stage procedure. All surgeries were performed by the senior author. None of these patients had known exposure to cobalt or chromium, kidney disease or other metal implants elsewhere in their bodies. Each prospectively provided blood samples and then yearly thereafter to measure cobalt and chromium levels for up to 11 years. Metal levels were measured using atomic absorption spectrophotometry and inductively coupled plasma mass spectrometry by a specialized trace element analysis laboratory. Acetabular component position was evaluated using Einzel-Bild-Röentgen-Analysis (EBRA) software. Contact patch to rim (CPR) distance was computed as described by Langton et al JBJS Br 91: 2009. A mixed model linear regression analysis was performed to evaluate long term trends, and multivariate analysis was performed to examine effects of implant and patient covariates on the metal ion levels. One bilateral patient underwent revision for femoral loosening, all other patients were clinically well-functioning at the time of last follow-up (ave 89 mos). The median pre-operative Co was below the detection limit (d.l) of 0.3μg/L and the median pre-operative Cr was 0.069μg/L (d.l. 03μg/L). Metal levels increased within the first year then decreased and stabilized (fig 1). For unilaterals over all time intervals, the median Co was 1.06 μg/L, while the median Cr was 1.58 μg/L. For bilaterals, the mean post-operative Co was 2.80 μg/L, while the mean Cr was 5.80 μg/L. Generally, Cr levels were higher at all time points than Co. Bilateral patients had Co values 1.96 times greater on average than the unilateral patients (p<0.001). None of the possible covariates studied (femoral size, cup abduction angle, cup anteversion, CPR distance, activity, BMI and testing method) were related to the assay values. The results of this study have shown that serum metal levels in well functioning implants can be low and do not increase over time. These are among the lowest levels reported for resurfacing devices and comparable to levels reported for well functioning small diameter metal-on-metal total hips. The study is limited due to the relatively small sample size and limited range of values for the covariates studied. However, it included patients who were active, female or bilateral and we collected ion levels up to 11 years. We now recommend that patients who have well-oriented Conserve Plus components with stable radiographic interfaces and no incidences of unexplained pain or hip noises be scheduled for follow-up every 2–3 years, rather than annually


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 65 - 65
1 Jul 2020
Wilkinson JM Gartland A Morell D Shah K Sudsok P
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Local and systemic concentrations of cobalt (Co) and chromium (Cr) ions may be elevated in patients with accelerated tribo-corrosion at prosthesis bearing surfaces and modular taper junctions. Previous studies by us and others have shown that exposure to these metals negatively affect the viability and function of osteoblasts and osteoclasts in vitro, with implications for bone health. More recently, we have observed an increase in total bone mineral density and reduced bone turnover (TRAP5b and osteocalcin) in patients with well-functioning metal-on-metal hip resurfacing (MOMHR). Here, we provide data to support the hypothesis that osteoclast differentiation and function is altered in this patient population, and that this effect is transferrable through their serum.

Patients with well-functioning MOMHR (n=18) at median follow-up of 8 years were individually matched for gender, age and time-since-surgery to a low-exposure group consisting of patients with metal-on-polyethylene total hip arthroplasty (THA). The median circulating concentrations of Co and Cr for the MOMHR group were 2.53µg/L and 2.5µg/L respectively, compared to 0.02µg/L and 0.03µg/L for the THA group. Monocyte fraction of peripheral blood was isolated from these patients, seeded onto dentine wafers and differentiated into osteoclasts using media supplemented with RANKL and M-CSF (osteoclastogenic media, OM). Cultures were monitored for the onset of resorption, following which they were treated with OM, autologous serum or serum from the other individual within the matched MOMHR - THA pair, all supplemented with RANKL and M-CSF. At the end of the culture, cells were TRAP stained and quantified for total osteoclast number, number of resorbing osteoclasts and percentage resorption using the CellD Software Package (Olympus, Southend-on-Sea, U.K.).

For cells differentiated in osteoclastogenic media, the resorbing ability of osteoclasts derived from MOMHR patients was reduced by 30% (P=0.046) compared to THA. Correlation analyses showed that chronic exposure to Co and Cr trends towards negative association with resorption ability of these osteoclasts (r = −0.3, P=0.06). Furthermore, the resorbing ability of osteoclasts generated from MOMHR patients and differentiated in autologous serum was reduced 33% (p < 0 .0001), whilst matched THA serum caused a smaller reduction of 14% (p < 0 .01). When cells derived from THA patients were differentiated in autologous serum, the resorbing ability of osteoclasts was similarly reduced by 35% (p < 0 .0001), whilst the matched MOMHR serum also caused a reduction of 21% (p < 0 .0001).

Reduced osteoclastogenic response of precursor cells from patients with higher circulating Co and Cr suggests an inherent change in their potential to differentiate into functional osteoclasts. The data also suggests that functional response of mature osteoclasts generated from patient precursor cells are dependent on the prior systemic metal concentrations and the presence of higher circulating CoCr in patients with MOMHR. These effects are modest, but may explain the subtle increase in systemic bone mineral density and decreased bone turnover observed in patients after 8 years exposure compared to age, sex, and exposure-time matched patients who received a conventional THA.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_15 | Pages 103 - 103
1 Nov 2018
Gill RHS
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Metal on metal hip replacements have been one of worst failures in recent years in terms of orthopaedic implants. Some of these devices have had catastrophic failure rates, with reports of 48% failure at 6 years. The failure of these devices has led to considerable suffering, pain and reduction in quality of life; consequently, they have given rise to high costs and multi-million-dollar legal cases. This talk will describe the history of the current metal on metal failure and discuss some of the reasons why might have occurred. It will also consider the reasons that wear debris arising from the trunnion is worse in terms of biological activity then that arising from the bearing surfaces.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_12 | Pages 2 - 2
1 Mar 2013
Hexter A Panagiotidou A Singh J Skinner J Hart A
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The articulating surface replacement (ASR) XL stemmed total hip replacement and ASR resurfacing hip systems were recalled by DePuy due to a high prevalence of early failure. The ASR XL has a greater failure rate than the ASR resurfacing, which has been increasingly attributed to wear and corrosion at the taper interface between the female taper surface of the femoral head and the male taper (trunnion) of the femoral stem. The aim of this study was to quantify the prevalence and severity of taper corrosion in retrieved ASR XL hip components. A peer-reviewed subjective corrosion scoring system was used to quantify corrosion in a consecutive series of the 50 ASR XL hip components (head components – n=44; femoral stems – n=6) at our retrieval centre. Bearing surface wear (femoral head and acetabular cup combined) was quantified and a value of <5 microns was defined as low-wearing. Subsequent profilometry analysis was undertaken in the low-wearing hips to quantify material loss from the taper interface. 90% of components showed evidence of corrosion, with at least moderate corrosion observed in 58%. There were 17 low-wearing hips which had a median material loss from the taper interface of 3.51mm. 3. (range: 0.612–9.443). The median linear depth of material loss was 33μm (range: 8.5–78.0). No relationship was observed between taper corrosion and serum cobalt (r=0.204, p=0.2712) or chromium (r=0.146, p=0.432) metal ions. Wear and material loss from metal-on-metal (MoM) hips is associated with pseudotumour formation and adverse soft-tissue reactions. We have shown that taper corrosion is extremely common in failed ASR XL hips and that wear occurs in the same degree of magnitude as at the bearing surface also occurs at the taper interface. Therefore our findings support the emerging concept of ‘taper failure’, whereby the taper is the predominate reason for failure of MoM hips. Future work must determine the relative contributions of the bearing surface and the taper interface to serum cobalt and chromium metal ion levels


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 356 - 356
1 Sep 2005
Nevelos J Pickard J Bowsher J Shelton J
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Introduction and Aims: Metal-on-metal (MOM) hips offer an attractive solution for hip arthroplasty. However, concerns remain over the optimum metallurgical condition of the cobalt chrome alloy and also the optimum bearing diameter to produce to least possible wear. Method: Hip bearings of 28, 40 and 56mm high carbon cobalt chrome diameter were tested, all were HIPed and Solution annealed, apart from four 40mm bearings were left ‘as cast’. Radial clearances were controlled at 110 microns, initial surface finish was Sa 0.05 microns, and the sphericity deviation was 4–8 microns. A multi-directional biaxial rocking hip joint simulator was used. All bearing couples were initially subjected to three million cycles of standard physiological walking (2450 N max, 1 Hz) followed by four million cycles of severe gait tests, i.e. slow walking (0.62 Hz) and fast jogging (4500 N max, 1.75 Hz). Results: In the diameter study, the 56mm bearings produced the lowest wear rates for all patient activities simulated followed by the 40 and 28mm bearings. However, the running-in wear was greatest for the 56mm bearings followed by the 28 and 40mm bearings. All surface wear patterns showed very similar characteristics, suggesting similar wear processes. This would indicate that larger diameters are indeed better in terms of wear in the long term, but may produce slightly more wear initially, which has been reflected in increased ion release in short term studies. Comparing the 40mm as cast and heat-treated bearings, running-in wear was observed for both material groups in the first million cycles, generating wear rates of 2.3 mm3/million cycles and 2.4 mm3/million cycles for the HIPed/solution heat treated and as cast components respectively, indicating no statistical difference (p > 0.9). Under steady-state wear conditions, the combined normal walking wear rate was also similar for both groups, showing 0.48 mm3/106 cycles (p > 0.2). Under simulated fast jogging cycles, the results again showed no statistical difference in wear performance between the two groups (p > 0.3), generating approximately a 10-fold increase in volumetric wear compared to normal walking, showing 4.4 mm3/106 cycles. Conclusion: This wear testing program, which used both standard and adverse testing conditions, has shown that heat treatments (HIP and solution anneal) do not affect the wear rates of cast cobalt chrome alloy. Further, this testing has confirmed that larger diameter bearings do indeed produce less wear in the long term


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