Despite advancements, revision rates following total ankle replacement (TAR) are high in comparison to other total joint replacements. This explant analysis study aimed to investigate whether there was appreciable metal particulate debris release from various contemporary TARs by describing patterns of material loss. Twenty-eight explanted TARs (9 designs: 3 fixed and 6 mobile bearing), revised for any reason, were studied. The articulating surfaces of the metal tibial and talar components as well as the polyethylene insert were assessed for damage features using light microscopy. Based on the results of the microscopic analysis, scanning electron microscopy with energy dispersive X-ray spectroscopy was performed to determine the composition of embedded debris identified, as well as non-contacting 3D profilometry. Pitting, indicative of material loss, was identified on the articulating surfaces of 54% of tibial components and 96% of talar components. Bearing constraint was not found to be a factor, with similar proportions of fixed and mobile bearing metal components showing pitting. More cobalt-chromium than titanium alloy tibial components exhibited pitting (63% versus 20%). Significantly higher average surface roughness (Sa) values were measured for pitted areas in comparison to unpitted areas of these metal components (p<0.05). Additionally, metallic embedded debris (cobalt-chromium likely due to pitting of the tibial and talar components or titanium likely from loss of their porous coatings) was identified in 18% of polyethylene inserts. The presence of hard 3. rd. body particles was also indicated by macroscopically visible sliding plane scratching, identified on 79% of talar components. This explant analysis study demonstrates that metal debris is released from the articulating surfaces and the coatings of various contemporary TARs, both fixed and mobile bearing. These findings suggest that metal debris release in TARs may be an under-recognised issue that should be considered in the study of painful or failed TAR moving forwards

Glenoid failure remains the most common mode of total shoulder arthroplasty failures. Porous tantalum metal (Trabecular Metal™, Zimmer) have grown in popularity in hip and knee arthroplasty. First-generation porous tantalum metal-backed glenoid components demonstrated metal debris, resulted in failure, and were revised to second-generation glenoid implants. Evidence for second-generation porous tantalum metal implants in shoulder arthroplasty is sparse.1–4 The purpose of this study was to assess clinical and radiographic outcomes in a series of patients with second-generation porous tantalum glenoid components at a minimum two-years postoperative. We retrospectively reviewed the clinical and radiographic outcomes of patients who received a second-generation porous tantalum glenoid component anatomic shoulder arthroplasty between May 2009 and December 2017 with minimum 24 months follow-up. The shoulder arthroplasties were performed by one of two senior fellowship-trained surgeons. We collected postoperative clinical outcome indicators: EQ5D visual analog scale (VAS), Western Ontario Osteoarthritis of the Shoulder (WOOS) Index, American Shoulder and Elbow Surgeons (ASES) Score, and Constant Score (CS). Radiographic review was performed by an independent fellowship-trained surgeon. The Endrizzi metal debris grading system1 was utilized to grade metal debris. We computed descriptive statistics and compared outcome scores between groups via the non-parametric Wilcoxon rank-sum test, with group-wise comparisons defined by: metal debris and humeral head migration (secondary analyses). Thirty-five patients [23 male (65.7%) and 12 female (34.3%)] with 40 shoulder replacements participated in the study. Forty of 61 shoulders (65.6%) had an average of 64 ± 20.3 months follow-up (range 31 to 95). Average BMI was 27.5 ± 4.4 kg/m2 (range 19.5 to 39.1). The average postoperative EQ5D VAS at final follow-up was 74.6 ± 22.5, WOOS Index 87.9 ± 16.6, ASES Score 88.3 ± 10.9, and CS 80.4 ± 13. At final follow-up, 18 of 40 shoulders (45%) had metal debris [15 of 40 (37.5%) Endrizzi grade 1 and three of 40 (7.5%) Endrizzi grade 2], and 22 of 40 shoulders (55%) did not show evidence of metal debris. There was one non-revision reoperation (open subscapularis exploration), one shoulder with anterosuperior escape, three shoulders with glenoid radiolucencies indicative of possible glenoid loosening, and nine shoulders with superior migration of the humeral head (>2mm migration at final follow-up compared to immediate postoperative). When comparing postoperative scores between patients with vs without metal debris, we found no statistically significant difference in the EQ5D VAS, WOOS Index, ASES Score and CS. On further analyses, when comparing superior migration of the humeral head and postoperative outcomes scores, we found no statistically significant difference. We report the longest published follow-up with clinical and radiographic outcomes of second-generation porous tantalum glenoid anatomic shoulder arthroplasties. In this series of patients, 45% of total shoulder arthroplasties with a second-generation porous tantalum glenoid implant had radiographic evidence of metal debris. This metal debris was not statistically associated with poorer postoperative outcomes. Further investigation and ongoing follow-up are warranted

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

We sought to establish the incidence of joint failure secondary to adverse reaction to metal debris (ARMD) following metal-on-metal hip resurfacing in a large, three surgeon, multicentre study involving 4226 hips with a follow-up of 10 to 142 months. Three implants were studied: the Articular Surface Replacement; the Birmingham Hip Resurfacing; and the Conserve Plus. Retrieved implants underwent analysis using a co-ordinate measuring machine to determine volumetric wear. There were 58 failures associated with ARMD. The median chromium and cobalt concentrations in the failed group were significantly higher than in the control group (p < 0.001). Survival analysis showed a failure rate in the patients with Articular Surface Replacement of 9.8% at five years, compared with < 1% at five years for the Conserve Plus and 1.5% at ten years for the Birmingham Hip Resurfacing. Two ARMD patients had relatively low wear of the retrieved components. Increased wear from the metal-on-metal bearing surface was associated with an increased rate of failure secondary to ARMD. However, the extent of tissue destruction at revision surgery did not appear to be dose-related to the volumetric wear

Objectives. We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr. Methods. For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood. Results. A CoCr JFR > 1 showed a specificity of 83% (77% to 88%) and sensitivity of 63% (55% to 70%) for the detection of severe ALVAL and/or SOTP. In patients with CoCr JFRs > 1, the median blood Cr to serum Cr ratio was 0.99, compared with 0.71 in patients with CoCr JFRs < 1 (p < 0.001). Regression analysis demonstrated that the blood Cr to serum Cr value was positively associated with the JF Co concentration (p = 0.011) and inversely related to the JF Cr concentration (p < 0.001). Conclusion. Elevations in CoCr JFRs are associated with adverse biological (severe ALVAL) or tribocorrosive processes (SOTP). Comparison of serum Cr with blood Cr concentrations may be a useful additional clinical tool to help to identify these conditions. Cite this article: D. J. Langton, S. Natu, C. F. Harrington, J. G. Bowsher, A. V. F. Nargol. Is the synovial fluid cobalt-to-chromium ratio related to the serum partitioning of metal debris following metal-on-metal hip arthroplasty? Bone Joint Res 2019;8:146–155. DOI: 10.1302/2046-3758.83.BJR-2018-0049.R1

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

We report a prospective study of the liner-metal interfaces of modular uncemented acetabular components as sources of debris. We collected the pseudomembrane from the screw-cup junction and the empty screw holes of the metal backing of 19 acetabula after an average implantation of 22 months. Associated osteolytic lesions were separately collected in two cases. The back surfaces of the liners and the screws were examined for damage, and some liners were scanned by electron microscopy. The tissues were studied histologically and by atomic absorption spectrophotometry to measure titanium content. The pseudomembrane from the screw-cup junction contained polyethylene debris in seven specimens and metal debris in ten. The material from empty screw holes was necrotic tissue or dense fibroconnective tissue with a proliferative histiocytic infiltrate and foreign-body giant-cell reaction. It contained polyethylene debris in 14 cases and metal in five. The two acetabular osteolytic lesions also showed a foreign-body giant-cell reaction to particulate debris. The average titanium levels in pseudomembranes from the screw-cup junction and the empty screw holes were 959 micrograms/g (48 to 11,900) and 74 micrograms/g (0.72 to 331) respectively. The tissue from the two lytic lesions showed average titanium levels of 139 and 147 micrograms/g respectively. The back surfaces of the PE liners showed surface deformation, burnishing, and embedded metal debris. All 30 retrieved screws demonstrated fretting at the base of the head and on the proximal shaft. Non-articular modular junctions create new interfaces for the generation of particulate debris, which may cause granulomatous reaction

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

We undertook a retrospective cohort study to determine clinical outcomes following the revision of metal-on-metal (MoM) hip replacements for adverse reaction to metal debris (ARMD), and to identify predictors of time to revision and outcomes following revision. Between 1998 and 2012 a total of 64 MoM hips (mean age at revision of 57.8 years; 46 (72%) female; 46 (72%) hip resurfacings and 18 (28%) total hip replacements) were revised for ARMD at one specialist centre. At a mean follow-up of 4.5 years (1.0 to 14.6) from revision for ARMD there were 13 hips (20.3%) with post-operative complications and eight (12.5%) requiring re-revision. . The Kaplan–Meier five-year survival rate for ARMD revision was 87.9% (95% confidence interval 78.9 to 98.0; 19 hips at risk). Excluding re-revisions, the median absolute Oxford hip score (OHS) following ARMD revision using the percentage method (0% best outcome and 100% worst outcome) was 18.8% (interquartile range (IQR) 7.8% to 48.3%), which is equivalent to 39/48 (IQR 24.8/48 to 44.3/48) when using the modified OHS. Histopathological response did not affect time to revision for ARMD (p = 0.334) or the subsequent risk of re-revision (p = 0.879). Similarly, the presence or absence of a contralateral MoM hip bearing did not affect time to revision for ARMD (p = 0.066) or the subsequent risk of re-revision (p = 0.178). . Patients revised to MoM bearings had higher rates of re-revision (five of 16 MoM hips re-revised; p = 0.046), but those not requiring re-revision had good functional results (median absolute OHS 14.6% or 41.0/48). Short-term morbidity following revision for ARMD was comparable with previous reports. Caution should be exercised when choosing bearing surfaces for ARMD revisions. Cite this article: Bone Joint J 2014;96-B:1600–9

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

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

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

Objectives

Several studies have reported elevated blood cobalt (Co) and chromium (Cr) concentrations in patients with total knee replacements (TKRs). Up to 44% of tissue samples taken from patients with failed TKRs exhibit histological evidence of metal sensitivity/ALVAL. In simulated conditions, metal particles contribute approximately 12% of total wear debris in TKR. We carried out this investigation to determine the source and quantity of metal release in TKRs.

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

In our independent centre, in the period from January 2003 to august 2008, over 1100 36mm MoM THRs have been implanted as well as 155 Birmingham Hip Resurfacing procedures, 402 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems. During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 11 failures of this nature in patients with ASR implants (10 females) and 2 in the 36 MoM THR group (one male one female). Tissue specimens from revision surgery showed varying degrees of ‘ALVAL’ as well as consistently high numbers of histiocytes. Metal debris was also a common finding. A fuller examination of our ASR cohort as a whole has shown that smaller components placed with inclinations > 45° and anteversions < 10 or > 20° are associated with increased metal ion levels. The 11 ASR failed joints were all sub optimally positioned (by the above definition), small components. Explant analysis using a coordinate measuring machine and out of roundness device confirmed greater than expected wear of each component. The lower number of failures in the 36mm MoM group, as well as the equal sex incidence, suggests that the majority of these failures are due to the instigation of an immune reaction by large amounts of wear debris rather than adverse reactions to well functioning joints. It is likely that small malpositioned ASRs function in mixed to boundary lubrication, and this, combined with the larger radius of these joints compared to the 36mm MoM joints, results in more rapid wear

Aims. To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Methods. Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed. Results. A total of 93 patients were randomized (46 TM; 47 POLY). No significant or clinically important differences were found with patient-reported outcomes at 24-month follow-up. Regarding the glenoid components, there were no complications or revision surgeries in either group. Grade 1 metal debris was observed in three (6.5%) patients with TM glenoids at 24 months but outcomes were not negatively impacted. Conclusion. Early results from this RCT showed no differences in disease-specific QOL, radiographs, complication rates, or shoulder function between uncemented second-generation TM and cemented POLY glenoids at 24 months postoperatively. Revision surgeries and reoperations were reported in both groups, but none attributed to glenoid implant failure. At 24 months postoperatively, Grade 1 metal debris was found in 6.5% of patients with a TM glenoid but did not negatively influence patient-reported outcomes. Longer-term follow-up is needed and is underway. Cite this article: Bone Jt Open 2021;2(9):728–736

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

In our independent centre, from 2002 to 2009, 155 BHRs (mean F/U 60 months) have been implanted as well as 420 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems (mean F/U 35). During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 17 failures of this nature in patients with ASR implants (12 females) and 0 in the BHR group. This amounts to a failure of 3.5% in the ASR group. Tissue specimens from revision surgery showed varying degrees of “ALVAL” as well as consistently high numbers of histiocytes. Particulate metal debris was also a common finding. The mean femoral size and acetabular anteversion and inclination angles of the ARMeD group/all asymptomatic patients was 45/49mm (p< 0.001), 27/20°(p< 0.001) and 53/48°(p< 0.08). Median blood chromium(Cr) and cobalt(Co) was 29 and 69 μg/L respectively in the ARMeD group versus 3.9 and 2.7 μg/L in the asymptomatic patients (n=160 with ion levels). Explant analysis confirmed greater rates of wear than expected. Lymphocyte proliferation studies involving ARMeD patients showed no hyper reactivity to Cr and Co in vitro implying that these adverse clinical developments are mediated by a toxic reaction or a localised immune response. Our overall results suggest that the reduced arc of cover of the fourth generation ASR cup has led to an increased failure rate secondary to the increased generation of metal debris. This failure rate is 7% in ASR devices with femoral components _47mm

We conducted a retrospective study to assess the prevalence of adverse reactions to metal debris (ARMD) in patients operated on at our institution with metal-on-metal (MoM) total hip replacements with 36 mm heads using a Pinnacle acetabular shell. A total of 326 patients (150 males, 175 hips; 176 females, 203 hips) with a mean age of 62.7 years (28 to 85) and mean follow-up of 7.5 years (0.1 to 10.8) participating in our in-depth modern MoM follow-up programme were included in the study, which involved recording whole blood cobalt and chromium ion measurements, Oxford hip scores (OHS) and plain radiographs of the hip and targeted cross-sectional imaging. Elevated blood metal ion levels (> 5 parts per billion) were seen in 32 (16.1%) of the 199 patients who underwent unilateral replacement. At 23 months after the start of our modern MoM follow-up programme, 29 new cases of ARMD had been revealed. Hence, the nine-year survival of this cohort declined from 96% (95% CI 95 to 98) with the old surveillance routine to 86% (95% CI 82 to 90) following the new protocol. Although ARMD may not be as common in 36 mm MoM THRs as in those with larger heads, these results support the Medicines and Healthcare Products Regulatory Agency guidelines on regular reviews and further investigations, and emphasise the need for specific a follow-up programme for patients with MoM THRs. Cite this article: Bone Joint J 2014; 96-B:1610–17