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

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

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

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

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

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

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

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

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

Introduction:. When having to remove broken or embedded metal implants using high speed burrs, the consequence is often a significant amount of metal debris which becomes embedded in the soft tissues. This may then act as a source for a foreign body inflammatory reaction or as a third body wear in the situation of joint arthroplasty. We describe a simple, cheap and effective method of reducing this debris using only a sterile water-based lubricating gel. Materials & Methods:. Several experimental surgical models consisting of porcine muscle over a polyethylene tube with a large fragment titanium locking plate and screw secured to it were constructed. In 8 separate models a screw head locked within the plate was subjected to 90 seconds of high speed burring to create debris. On 4 models no water-based lubricating gel was utilized and on the remaining 4 the surrounding soft tissues were coated in the water-based lubricating gel (AQUAGEL, Halliburton – 42g £1.98). All models were then irrigated with NaCl 500mls using a 20mlsl syringe under manual pressure. Images were then captured after irrigation. The amount of debris was quantified by processing with ImageJ (a public domain, Java-based image processing program developed at the National Institutes of Health and is a computer automated program for counting particles.) The results were then statistically analysed using a student t test (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). Results:. the images from the models with water-based gel were shown to have a statistically significant difference in particle number and area within the soft tissues (p=0.001). Conclusion:. We have shown that using a safe, cheap and easily available water-based lubricating gel reduces the amount of embedded debris when burring metal implants using a high-speed burr

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