Objectives. Modular dual-mobility (MDM) constructs are used to reduce dislocation rates after total hip replacement (THR). They combine the advantages of dual mobility with the option of supplementary acetabular screw fixation in complex revision surgery. However, there are concerns about adverse reaction to metal debris (ARMD) as a result of fretting corrosion between the metal liner and shell. Methods: The aim of this systematic review was to find and review all relevant studies to establish the outcomes and risks associated with MDM hip replacement. All articles on MDM THRs in the Medline, EMBASE, CINAHL, Cochrane Library, and Prospero databases were searched. A total of 14 articles were included. A random intercept logistic regression model was used for meta-analysis, giving estimated average values. Results: There were 6 cases of ARMD out of 1312 total. Estimated median incidence of ARMD from meta-analysis was 0.3% (95% CI 0.1 – 1.4%). Mean postoperative serum Cobalt was 0.81 μg/L (95% CI 0.33 – 1.29 μg/L), and Chromium was 0.77 μg/L (95% 0.35 – 1.19 μg/L), from 279 cases in 7 studies. Estimated median incidence of a serum cobalt or chromium ion measurement ≥1 μg/L was 7.9% (95% CI 3.5 – 16.8%), and ≥7 μg/L was 1.8% (95% CI 0.7 – 4.2%). Conclusions: ARMD is a rare but significant complication following total hip replacement using a MDM construct. Its incidence appears higher than that reported in non-metal-on-metal (MoM) hip replacements but lower than that of MoM hip replacements. MDM hip replacements are associated with raised serum metal ion levels postoperatively, but there was no correlation with worse clinical hip function within studies. Studies were poor quality and at high risk of confounding. Pending further work, MDM constructs should be used with caution, reserved for select cases at particularly high risk of dislocation

Objectives. Few studies have assessed outcomes following non-metal-on-metal hip arthroplasty (non-MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD). We assessed outcomes following non-MoMHA revision surgery performed for ARMD, and identified predictors of re-revision. Methods. We performed a retrospective observational study using data from the National Joint Registry for England and Wales. All non-MoMHAs undergoing revision surgery for ARMD between 2008 and 2014 were included (185 hips in 185 patients). Outcome measures following ARMD revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using Cox regression. Results. Intra-operative complications occurred in 6.0% (n = 11) of the 185 cases. The cumulative four-year patient survival rate was 98.2% (95% CI 92.9 to 99.5). Re-revision surgery was performed in 13.5% (n = 25) of hips at a mean time of 1.2 years (0.1 to 3.1 years) following ARMD revision. Infection (32%; n = 8), dislocation/subluxation (24%; n = 6), and aseptic loosening (24%; n = 6) were the most common re-revision indications. The cumulative four-year implant survival rate was 83.8% (95% CI 76.7 to 88.9). Multivariable analysis identified three predictors of re-revision: multiple revision indications (hazard ratio (HR) = 2.78; 95% CI 1.03 to 7.49; p = 0.043); selective component revisions (HR = 5.76; 95% CI 1.28 to 25.9; p = 0.022); and ceramic-on-polyethylene revision bearings (HR = 3.08; 95% CI 1.01 to 9.36; p = 0.047). Conclusions. Non-MoMHAs revised for ARMD have a high short-term risk of re-revision, with important predictors of future re-revision including selective component revision, multiple revision indications, and ceramic-on-polyethylene revision bearings. Our findings may help counsel patients about the risks of ARMD revision, and guide reconstructive decisions. Future studies attempting to validate the predictors identified should also assess the effects of implant design (metallurgy and modularity), given that this was an important study limitation potentially influencing the reported prognostic factors. Cite this article: G. S. Matharu, A. Judge, D. W. Murray, H. G. Pandit. Outcomes following revision surgery performed for adverse reactions to metal debris in non-metal-on-metal hip arthroplasty patients: Analysis of 185 revisions from the National Joint Registry for England and Wales. Bone Joint Res 2017;6:405–413. DOI: 10.1302/2046-3758.67.BJR-2017-0017.R2

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

Introduction. Adverse reaction to metal debris (ARMD) is an increasingly recognised complication of metal-on-metal hip arthroplasty. A previous study described poor results following revision and recommended early intervention. 1. We determined the outcome of revision for ARMD and present the largest case series to date. Methods. Between 2005 and 2010, 98 patients (101 hips) underwent revision for ARMD. The diagnosis of ARMD was based on clinical history, examination, appearance at revision and histology. Patients were reviewed at 3, 6 and 12 months and annually thereafter. Patient satisfaction, Harris hip scores (HHS) and metal ions were analysed. Results. 54 patients (55 hips) with an average age of 58 years (29 to 81 years) completed minimum one year follow-up (range 1 to 5 years). The mean HHS improved from 49.7 (10 to 79) to 86.3 (40 to 100). Forty-five (81%) patients were satisfied and nine (16%) patients were not satisfied with the outcome. The mean serum cobalt 24.5 (1.65 to 96.6) improved to 1.17 (0.31 to 6.99). Two patients died from unrelated diseases. There were 8 (14%) dislocations and one (1.8%) sciatic nerve palsy that has not recovered. Eight (14%) patients needed re-revision (dislocation: 5 and pain: 3). 26 % had severe soft tissue damage. Six patients have persistent pain and four had recurrent effusions. There were no dislocations in the most recent 50 cases. Discussion. Treatment of ARMD is technically demanding because extensive soft tissue damage can compromise stability. Early results in the current study were promising. Early intervention reduced the dislocation rate and appeared to have a positive impact on outcome. A small group of patients may have persistent pain and recurrent effusions that may require re-revision

Recent case reports have described V40 taper failure with clinically relevant adverse reaction to metal debris (ARMD). The real incidence of V40 taper damage and potential consequences are currently unclear, however. Aim of this study is therefore, to evaluate the long-term incidence of pseudotumors in a consecutive series of THA with V40 taper and identify potential influencing factors. From 2006 to 2007 a total number of 120 patients (127 hips) received either an uncemented (Accolade©) or cemented hip stem (ABGII©), both with V40 taper (Stryker© Mahwah, New Jersey, USA). They all were combined with 36 mm Vitallium (CoCrMo) heads and uncemented cups (Trident©) with XLPE inlays. 11,2 +/− 0,5 years post-op 82 patients with 87 hips (mean age 74 years, 58 % female) underwent clinical (PROMs) and radiographic evaluation. In 71 patients (75 hips) MARS- MRI of the hip was performed. 38 patients were lost to follow-up. In 81 patients (86 hips) chrome and cobalt levels were determined. MRI-investigation revealed 20 pseudotumors (26%) and 18 of them had a diameter of >2cm. Patients with pseudotumors had significant higher median cobalt ion levels compared to those without (2,85 μg/l vs. 1,32 μg/l; p=0,022) and a significant correlation between pseudotumors and cobalt levels was found. Radiographic osteolysis was associated with pseudotumors as well (p= 0,014). Neither approach, BMI, gender, age, type of stem, head length, inclination nor heterotope ossification showed a significant correlation to pseudotumor occurrence. Due to the high incidence of local ARMD in in asymptomatic patients with V40 taper and metal heads we recommend regular post-operative follow-up investigations including routine metal ion screening and consecutive MRI investigation upon elevation

A-70-year old woman underwent uncomplicated total hip arthroplasty using a titanium modular stem with a 46mm CoCr femoral head, a titanium shell, and a metal linear (Wright Medical Technology). Eight years after implantation, she presented with a painful left hip. A pelvic radiograph revealed adequate positioning of both hip implants without any signs of wear of loosening. CT scanning confirmed the presence of a 5 × 5 cm soft tissue mass in the ilium above the cup component accompanied by the iliac fracture. The patient was diagnosed as having an adverse reaction to metal debris (ARMD) after a metal-on-metal THA and revision was performed. Perioperatively?tissue necrosis and partial destruction of the abductor mechanism were found in the absence of any macroscopic infection. Both the neck trunnion and bore of the head showed slight signs of corrosion. The modular neck was revised with a ceramic 28mm head and a new dual-mobility liner(Zimmer Biomet). The iliac fracture was fixed with a porous trabecular metal augment(Zimmer Biomet). The histopathology of tissue sample revealed extensively necrotic material with focal cellular areas of inflammatory cells containing macrophages and neutrophilas. Metalic debris was also scattered in the necrotic materials. After the revision, the patient was recovered without pain or dislocation, and iliac fracture was well fixed. Instability is a substantial problem in the revision of ARMD. Extensive necrosis with gross deficiency of the abductor mechanism is associated with postoperative dislocation. Revision of failed MoM THA a dual-mobility device an effective strategy

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

Abstract. Objectives. Modular dual-mobility (MDM) constructs are used to reduce dislocation rates after total hip replacement (THR). They combine the advantages of dual mobility with the option of supplementary acetabular screw fixation in complex revision surgery. However, there are concerns about adverse reaction to metal debris (ARMD) as a result of fretting corrosion between the metal liner and shell. Methods. The aim of this systematic review was to find and review all relevant studies to establish the outcomes and risks associated with MDM hip replacement. All articles on MDM THRs in the Medline, EMBASE, CINAHL, Cochrane Library, and Prospero databases were searched. A total of 14 articles were included. A random intercept logistic regression model was used for meta-analysis, giving estimated mean values. Results. There were 6 cases of ARMD out of 1312 total. Estimated median incidence of ARMD from meta-analysis was 0.3% (95% CI 0.1 – 1.4%). Mean postoperative serum Cobalt was 0.81 μg/L (95% CI 0.33 – 1.29 μg/L), and Chromium was 0.77 μg/L (95% 0.35 – 1.19 μg/L), from 279 cases in 7 studies. Estimated median incidence of a serum cobalt or chromium ion measurement ≥1 μg/L was 7.9% (95% CI 3.5 – 16.8%), and ≥7 μg/L was 1.8% (95% CI 0.7 – 4.2%). Conclusions. ARMD is a rare but significant complication following total hip replacement using a MDM construct. Its incidence appears higher than that reported in non-metal-on-metal (MoM) hip replacements but lower than that of MoM hip replacements. MDM hip replacements are associated with raised serum metal ion levels postoperatively, but there was no correlation with worse clinical hip function within studies. Studies were poor quality and at high risk of confounding. Pending further work, MDM constructs should be used with caution, reserved for select cases at particularly high risk of dislocation. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Adverse reaction to metal debris (ARMD) is well recognised as a complication of large head metal on metal total hip replacement (THR) leading to pain, bone and tissue loss and the need for revision surgery. An emerging problem of trunnionosis in metal on polyethylene total hip replacements leading to ARMD has been reported in a few cases. Increased metal ion levels have been reported in THR's with a titanium stem and a cobalt chrome head such as the Accolade-Trident THR (Stryker). We present 3 cases of ARMD with Accloade-Trident THR's with 36mm cobalt chrome head and a polyethylene liner. Metal ion levels were elevated in all three patients (cobalt 10.3 – 161nmol/l). Intraoperative tissue samples were negative for infection and inflammatory markers were normal. Abnormal fluid collections were seen in all three cases and bone loss was severe in one patient leading to a proximal femoral replacement. Histology demonstrated either a non-specific inflammatory reaction in a case which presented early or a granulomatous reaction in a more advanced case suggesting a local foreign body reaction. All patients had improved symptoms post-operatively. 1 patient who had staged bilateral Accolade-Trident THR's required revision of both THR's. ARMD in metal on polyethylene THR's with a titanium stem represents a potential emerging problem. Further studies are required to assess whether these occurrences are rare or represent the tip of an iceberg

Trunnionosis, due to mechanical wear and/or corrosion at the head stem taper junction, can occur in metal on polyethylene (MOP) hip implants. In some patients this results in severe soft tissue destruction or Adverse Reaction to Metal Debris (ARMD). The amount of material required to cause ARMD is unknown but analyses of retrieved hips may provide the answer to this clinically important question. We collected implants from 20 patients with failed hips with MOP bearings, revised due to ARMD. We collected clinical, imaging and blood test data. We graded the severity of taper corrosion (1 to 4), and quantified the volume of material loss from this junction. We compared our results with previous data collected for metal-on-metal (MOM) hips. The median time to revision of the MOP hips was 51.3 (23.1–56.4) months. All head tapers were moderately to severely corroded with a median corrosion score of 4. The median (range) of total material loss at the taper of the MOP hips was 3.9 mm. 3. (2.96 – 7.85 mm. 3. ) and the material loss rate was 1.4 mm. 3. / year (0.56 – 1.82). Comparison with MOM hips revealed no significant difference in taper material loss (p=0.7344) with a median rate of 0.81 mm. 3. / year (0.01–3.45). We are the first to quantify the volume of material loss at the head taper of hip implants with MOP bearings that were revised due to trunnionosis. This data indicates that a clinically significant dose of cobalt and chromium to induce ARMD is approximately 1.4 mm. 3. / year. We have identified a clinically significant volume of taper material loss in MOP hips

Aims

To determine the outcomes following revision surgery of metal-on-metal hip arthroplasties (MoMHA) performed for adverse reactions to metal debris (ARMD), and to identify factors predictive of re-revision.

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

Introduction. Large head total hip arthroplasty (THA) reduces dislocation rates and provides a theooretically larger range of motion. We hypothesised that this would translate into greater improvement in functional scores when compared to 28mm metal-on-polyethylene THA at 5 years. We believe ours to be the first in vivo comparison study. Methods. A multi-surgeon case-control study in a District General Hospital. The study group consisted of 427 patients with 452 hips, the 38mm uncemented metal-on-metal articulation THA (M2A/Bi-metric, Biomet UK). The control group consisted of 438 age and sex-matched patients with 460 28mm metal-on-polyethylene articulation THA (Exeter/Exeter or Exeter/Duraloc - Stryker UK. All patients were assessed in a physiotherapist led Joint Review Service as part of their standard follow up, with functional scoring using Oxford Hip (scored 0–48) and WOMAC scores (0–100). Results. The demographics for the 38mm and 28mm groups gave mean ages of 65.8 years and 66.4 years, 40.4% and 39.3% male respectively. Pre-operative functional scores were comparable, with Oxford Hip scores of 23.3 and 26.8 respectively, WOMAC 49 compared to 53. At each review point there was no statistical difference in either Oxford or WOMAC scores and this was sustained at 5 yrs. Dislocation rates in the 38mm group were lower (2.9% vs. 5%) though not statistically significant (p = 0.111). Revision rate was significantly higher in the larger head group, primarily due to adverse reaction to metal debris (4.6% vs. 2.0%). Conclusions. There is no functional difference between 38mm metal-on-metal THA and 28mm metal-on-polyethylene THA at five years. Dislocation rates were found to be lower in the 38mm THAs as would be expected, but this was not statistically significant. The difference in revision rates was found to be due to metal-on-metal adverse reactions to metal debris, and their use is therefore not advocated in the current climate

BACKGROUND. The most common salvage of a failed metal-on-metal hip resurfacing is to remove both the femoral and acetabular resurfacing components and perform a total hip replacement. The other choices are to perform an acetabular or femoral only revision. A one or two piece acetabular component or a polyethylene bipolar femoral component that matches the retained metal resurfacing acetabular component is used. The considerations in favor of performing a one component resurfacing revision are maintaining the natural femoral head size, limiting the surgical effort for the patient and surgeon, and bone conservation. There are often favorable cost considerations with single component revision surgery. The reasons for femoral component revision are femoral neck fracture, femoral component loosening and an adverse reaction to metal wear debris. Performing a femoral component only revision requires a well fixed and well oriented acetabular component. Acetabular revision is most often performed for an adverse reaction to metal wear debris or loosening. METHODS. 81 acetabular revisions and 46 femoral revisions were evaluated 4 to 14 years after surgery. 83% of patients had their initial surgery at outside institutions. The mean age was 46 and 65% of patients were women. A two piece titanium backed polyethylene component was used in 44 patients and a one or two piece metal component was used in 37. A dual mobility femoral prosthesis mated to a retained metal acetabular component was used for the femoral revisions and no conversions to a metal-on-metal total hip replacement were performed. We selected polyethylene acetabular components for patients with adverse reactions to metal wear debris if their femoral component was less than 48 mm or if there was no matching metal acetabular component available for their femoral component. We used dual mobility components for femoral loosening, femoral neck fractures and adverse reactions to metal wear debris in patients with well-fixed and well oriented metal acetabular components. Dual mobility components were also used if there are any concerns about the femoral component or in some older patients. We performed one component revisions rather than conversion to total hip replacement on 88% of patients presenting with failed resurfacing prostheses. RESULTS. There were no failures with polyethylene acetabular components. There were two failures due to ongoing adverse metal reactions in patients receiving metal revision acetabular components. There was one failure with a dual mobility prosthesis due to accelerated polyethylene wear from undetected edge loading on a retained worn metal acetabular component. There were two infections and one patient with continued pain. There were no dislocations. The average Harris Hip Score was 94. The UCLA activity score was 6 or greater for all but 4 patients. There were 6 revisions to total hip replacement. The Kaplan-Meier survivorship was 94%. 95% of patients rated their outcome as excellent or good. CONCLUSIONS. Failed metal-on-metal hip resurfacing prostheses can be successfully revised without conversion to total hip replacement in most instances. A detailed knowledge of matching prostheses is necessary. Polyethylene prostheses for the acetabular or femoral reconstruction are often needed

We present a consecutive case cohort of the first 100 Birmingham Hip Resurfacing (BHR)'s in 90 patients with a minimum follow up of 20 years. All procedures were performed by a single surgeon having commenced the study in 1998. The original cohort included 68 males with 75 hips (7 bilateral) and 22 females with 25 hips (3 bilateral). The mean age at index procedure was 52. Patients were recalled to review in clinic as per Medicines and Healthcare products Regulatory Agency guidelines with x-rays, metal ions and Harris Hip Scores recorded. After a minimum of 20 year follow-up review the known overall revision rate is 11%. 11 have died and 7 have been lost to review. In males the known revision rate is 4/75 (5%), 3 of which were due to early fractures and 1 revision for infection at 5 years. The known revision rate in females is 7/25 (28%) of which 6 were due to adverse reactions to metal debris; 3 at 7–8 yrs, 1 at 15 yrs, 2 at 18 years, and 1 at 2 months for avascular necrosis. The mean 20 year metal ions results were cobalt 36.6 nmol/l (range 7.4–232.1) and chromium 32.1 nmol/l (range 6–120.8). The mean Harris hip score was 88.5 (range 38.6–99.8). This case series with 20 years follow-up demonstrates excellent long term survival of the BHRs further to registry BHR data and similar to THR for same age recipients. Applying today's strict criteria for patient selection would likely improve survival rate further. BHR has not demonstrated the catastrophic revision rates associated with some metal-on-metal resurfacing and remains a safe option for those who meet the criteria

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

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

Increased revision rates and early failure of Metal-on-Metal (MoM) hip replacements are often due to adverse reaction to metal debris (ARMD). Cobalt is a major component of MoM joints and can initiate an immune response via activation of the innate immune receptor Toll-like receptor 4 (TLR4). This leads to increased secretion of inflammatory cytokines/chemokines e.g. CCL3 and CCL4. The aim of this study was to evaluate whether TLR4-specific neutralising antibodies can prevent cobalt-mediated activation of TLR4. MonoMac 6 (MM6) cells, a human macrophage cell line, were treated with two different TLR4-specific monoclonal antibodies followed by 0.75mM of cobalt chloride (CoCl2). Lipopolysaccharide (LPS), a known TLR4 agonist was used as a positive control. Enzyme-linked immunosorbent assay (ELISA) was used to assess CCL3/CCL4 protein secretion and real time- polymerase chain reaction (RT-PCR) allowed quantification of CCL3/CCL4 gene expression. MM6 cells treated with cobalt and LPS up-regulate CCL3 and CCL4 gene expression and protein secretion. MM6 cells pre-treated with both monoclonal antibodies prior to stimulation with 0.75mM CoCl2 for 16 hours demonstrated significant inhibition of both CCL3 and CCL4 secretion as well as gene expression (both p=<0.0001). One of the antibodies failed to inhibit chemokine expression and secretion in LPS treated cells. This study identifies for the first time the use of TLR4-specific monoclonal antibodies to prevent cobalt activation of TLR4 and subsequent inflammatory response. This finding demonstrates the potential to exploit TLR4 inhibition in the context of MoM joint replacements by contributing to the development of novel therapeutics designed to reduce the incidence of ARMD

Background. There has been a trend in the evolution of total hip arthroplasty towards increased modularity, with this increase in modularity come some potentially harmful consequences. Modularity at the neck shaft junction has been linked to corrosion, adverse reaction to metal debris and pseudotumor formation. The aim of this retrieval study is to assess whether the surface integrity of the polyethylene (PE) liner is affected by metal wear debris in a single implant design series of THA revised for trunnionosis. Method. A retrieval analysis of thirty dual-taper modular neck hip prostheses was performed, the mean time from implantation to revision was 2.7 years (1.02–6.2). The PE liners were analysed using a scanning electron microscope with an energy dispersive spectrometer to assess for metal particles embedded on the liner surface. Serum metal ion levels and inflammatory markers were also analysed. Results. There were small numbers of metal particles present on the PE liners. The mean number of metal particles per liner was 4 and the particles varied in size from 0.5–122μm mean 16μm. All patients had elevated metal ion levels: cobalt 6.02μg/l, chromium 1.22μg/l, titanium 3.11μg/l. The cobalt:chromium ratio was 7.55:1. The inflammatory markers were also marginally raised (ESR 17 CRP 10). Conclusion. These results suggest that retention of the PE liners may be reasonable when performing isolated revision of the femoral component in cases of failure at the modular neck stem junction; especially when the inner diameter of the liner is already optimized for head size and stability

Introduction. We investigated predictors of poor outcomes following metal-on-metal hip arthroplasty (MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD), to help inform the revision threshold and type of reconstruction. Patients and Methods. A retrospective cohort study was performed involving 346 MoMHAs revised for histologically confirmed ARMD at two specialist centres (245=hip resurfacing, 101=total hip arthroplasty). Numerous preoperative (blood metal ions and imaging) and intraoperative (findings, and components removed/implanted) factors were used to predict poor outcomes. Poor outcomes were postoperative complications (including re-revisions), 90-day mortality, and poor Oxford Hip Scores (<27/48). Multivariable logistic regression models for predicting poor outcomes were developed using stepwise selection methods. Results. Cumulative implant survival rate seven-years after ARMD revision was 87.0% (95% CI=81.0%-91.2%). Poor outcomes occurred in 39% (n=135). Shorter time (under four-years) from primary to revision surgery (odds ratio (OR)=2.12, CI=1.00–4.46) was the only preoperative predictor of poor outcomes. Pre-revision metal ions and imaging did not influence outcomes. Single-component revisions increased the risk of poor outcomes (acetabular or femoral vs. all component revisions; OR=2.99, CI=1.50–5.97). Intraoperative factors reducing the risk of poor outcomes included the posterior approach (OR=0.22, CI=0.10–0.49), revision head sizes ≥36mm (vs. <36mm: OR=0.37, CI=0.18–0.77), ceramic-on-polyethylene (OR vs. ceramic-on-ceramic=0.30, CI=0.14–0.66) and metal-on-polyethylene revision bearings (OR vs. ceramic-on-ceramic=0.37, CI=0.17–0.83). Discussion. This large cohort study demonstrated 39% of patients experience poor outcomes following MoMHA revision for ARMD. This information will help surgeons when counselling patient's pre-revision about the expected prognosis. No threshold exists for recommending ARMD revision, therefore surgeons must make decisions on an individual case basis. However, surgeons can make intraoperative decisions that influence outcomes following ARMD revision. Conclusion. We recommend optimal outcomes following ARMD revision may be achieved if surgeons use the posterior approach, revise all MoMHA components, and use ≥36mm ceramic-on-polyethylene or metal-on-polyethylene articulations