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.

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

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

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

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

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

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.

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.

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.

Aims

The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices.

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

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

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

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

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

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

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

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

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

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