Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties. There was wide variation in plasma cobalt and chromium levels, and MARS-MRI scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%). There was a significant difference in the median plasma cobalt and chromium levels between those with positive and negative MARS-MRI scans (p < 0.001). Compared with MARS-MRI as the potential reference standard for the diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt or chromium with a cut-off of > 7 µg/l was 57%. The specificity was 65%, positive predictive value was 52% and the negative predictive value was 69% in symptomatic patients. A lowered threshold of > 3.5 µg/l for cobalt and chromium ion levels improved the sensitivity and negative predictive value to 86% and 74% but at the expense of specificity (27%) and positive predictive value (44%). Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels

Aims

To establish the survivorship, function, and metal ion levels in an unselected series of metal-on-metal hip resurfacing arthroplasties (HRAs) performed by a non-designer surgeon.

Aims

We wished to investigate the influence of metal debris exposure on the subsequent immune response and resulting soft-tissue injury following metal-on-metal (MoM) hip arthroplasty. Some reports have suggested that debris generated from the head-neck taper junction is more destructive than equivalent doses from metal bearing surfaces.

Metal artefact reduction (MAR) MRI is now widely considered to be the standard for imaging metal-on-metal (MoM) hip implants. The Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended cross-sectional imaging for all patients with symptomatic MoM bearings. This paper describes the natural history of MoM disease in a 28 mm MoM total hip replacement (THR) using MAR MRI. Inclusion criteria were patients with MoM THRs who had not been revised and had at least two serial MAR MRI scans. All examinations were reported by an experienced observer and classified as A (normal), B (infection) or C1–C3 (mild, moderate, severe MoM-related abnormalities). Between 2002 and 2011 a total of 239 MRIs were performed on 80 patients (two to four scans per THR); 63 initial MRIs (61%) were normal. On subsequent MRIs, six initially normal scans (9.5%) showed progression to a disease state; 15 (15%) of 103 THRs with sequential scans demonstrated worsening disease on subsequent imaging.

Most patients with a MoM THR who do not undergo early revision have normal MRI scans. Late progression (from normal to abnormal, or from mild to more severe MoM disease) is not common and takes place over several years.

Cite this article: Bone Joint J 2013;95-B:1035–9.

Objectives

The aims of this piece of work were to: 1) record the background concentrations of blood chromium (Cr) and cobalt (Co) concentrations in a large group of subjects; 2) to compare blood/serum Cr and Co concentrations with retrieved metal-on-metal (MoM) hip resurfacings; 3) to examine the distribution of Co and Cr in the serum and whole blood of patients with MoM hip arthroplasties; and 4) to further understand the partitioning of metal ions between the serum and whole blood fractions.

Peri-articular soft-tissue masses or ‘pseudotumours’ can occur after large-diameter metal-on-metal (MoM) resurfacing of the hip and conventional total hip replacement (THR). Our aim was to assess the incidence of pseudotumour formation and to identify risk factors for their formation in a prospective cohort study.

A total of 119 patients who underwent 120 MoM THRs with large-diameter femoral heads between January 2005 and November 2007 were included in the study. Outcome scores, serum metal ion levels, radiographs and CT scans were obtained. Patients with symptoms or an identified pseudotumour were offered MRI and an ultrasound-guided biopsy.

There were 108 patients (109 hips) eligible for evaluation by CT scan at a mean follow-up of 3.6 years (2.5 to 4.5); 42 patients (39%) were diagnosed with a pseudotumour. The hips of 13 patients (12%) were revised to a polyethylene acetabular component with small-diameter metal head. Patients with elevated serum metal ion levels had a four times increased risk of developing a pseudotumour.

This study shows a substantially higher incidence of pseudotumour formation and subsequent revisions in patients with MoM THRs than previously reported. Because most revision cases were identified only after an intensive screening protocol, we recommend close monitoring of patients with MoM THR.

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

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

Aims. Fretting and corrosion at the modular head/neck junction, known as trunnionosis, in total hip arthroplasty (THA) is a cause of adverse reaction to metal debris (ARMD). We describe the outcome of revision of metal-on-polyethylene (MoP) THA for ARMD due to trunnionosis with emphasis on the risk of major complications. Patients and Methods. A total of 36 patients with a MoP THA who underwent revision for ARMD due to trunnionosis were identified. Three were excluded as their revision had been to another metal head. The remaining 33 were revised to a ceramic head with a titanium sleeve. We describe the presentation, revision findings, and risk of complications in these patients. Results. The patients presented with pain, swelling, stiffness, or instability and an inflammatory mass was confirmed radiologically. Macroscopic material deposition on the trunnion was seen in all patients, associated with ARMD. Following revision, six (18.2%) dislocated, requiring further revision in four. Three (9.1%) developed a deep infection and six (18.2%) had significant persistent pain without an obvious cause. One developed a femoral artery thrombosis after excision of an iliofemoral pseudotumor, requiring a thrombectomy. Conclusion. The risk of serious complications following revision MoP THA for ARMD associated with trunnionosis is high. In the presence of extensive tissue damage, a constrained liner or dual mobility construct is recommended in these patients. Cite this article: Bone Joint J 2018;100-B:720–4

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

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. Patients and Methods. We performed a retrospective observational study using National Joint Registry (NJR) data on 2535 MoMHAs undergoing revision surgery for ARMD between 2008 and 2014. The outcomes studied following revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using competing-risk regression modelling. Results. Intra-operative complications occurred in 40 revisions (1.6%). The cumulative five-year patient survival rate was 95.9% (95% confidence intervals (CI) 92.3 to 97.8). Re-revision surgery was performed in 192 hips (7.6%). The cumulative five-year implant survival rate was 89.5% (95% CI 87.3 to 91.3). Predictors of re-revision were high body mass index at revision (subhazard ratio (SHR) 1.06 per kg/m. 2 . increase, 95% CI 1.02 to 1.09), modular component only revisions (head and liner with or without taper adapter; SHR 2.01, 95% CI 1.19 to 3.38), ceramic-on-ceramic revision bearings (SHR 1.86, 95% CI 1.23 to 2.80), and acetabular bone grafting (SHR 2.10, 95% CI 1.43 to 3.07). These four factors remained predictive of re-revision when the missing data were imputed. Conclusion. The short-term risk of re-revision following MoMHA revision surgery performed for ARMD was comparable with that reported in the NJR following all-cause non-MoMHA revision surgery. However, the factors predictive of re-revision included those which could be modified by the surgeon, suggesting that rates of failure following ARMD revision may be reduced further. Cite this article: Bone Joint J 2017;99-B:1020–7

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

Outcomes following metal-on-metal hip replacement (MoMHR) revision surgery for adverse reactions to metal debris (ARMD) have been poor, and inferior compared with non-ARMD revisions. Subsequently, surgeons and worldwide authorities widely recommended early revision for ARMD, with a lower surgical threshold adopted. However, the impact of early surgery for ARMD is unknown. We compared the rates of adverse outcomes following MoMHR revision surgery in matched ARMD and non-ARMD patients. We performed a retrospective observational study using data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. All MoMHR patients subsequently undergoing revision surgery for any indication between August 2008 and August 2014 were eligible. ARMD and non-ARMD revisions were matched one-to-one for multiple potential confounding factors using propensity scores. Adverse outcomes following revision surgery (intra-operative complications, mortality, re-revision surgery) were compared between matched groups using regression analysis. In 2,576 matched MoMHR revisions (ARMD=1,288 and non-ARMD=1,288), intra-operative complications were similar between ARMD (2.4%) and non-ARMD (2.5%) revisions (odds ratio=0.97, 95% CI=0.59–1.60; p=0.899). All-cause mortality rates were lower following ARMD revision compared with non-ARMD revision (hazard ratio (HR)=0.43, 95% CI=0.22–0.86; p=0.018). All-cause re-revision rates were lower following ARMD revision compared with non-ARMD revision (HR=0.52, 95% CI=0.36–0.75; p<0.001). Compared with ARMD revision (5-years=94.3%), MoMHR revisions for infection (5-years=81.2%) and dislocation/subluxation (5-years=81.9%) had the lowest implant survival rates. Contrary to previous observations, MoMHRs revised for ARMD have approximately half the risk of re-revision and death compared to non-ARMD revisions. We suspect worldwide regulatory authorities have positively influenced outcomes following ARMD revision by widely recommending that surgeons exercise a lower revision threshold. Our findings suggest the threshold for ARMD revision surgery need not be lowered further. The high risk of failure following MoMHR revision for infection and dislocation is concerning

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

Recent studies have demonstrated that implant-specific blood metal ion thresholds exist in unilateral and bilateral metal-on-metal (MoM) hip arthroplasty patients, with these thresholds being most effective for identifying patients at low-risk of adverse reactions to metal debris (ARMD). We investigated whether these new blood metal ion thresholds could effectively identify patients at risk of ARMD in an external cohort of MoM hip arthroplasty patients. We performed a validation study involving 803 MoM hip arthroplasties implanted in 710 patients at three European centres (323=unilateral Birmingham Hip Resurfacing (BHR); 93=bilateral BHR; 294=unilateral Corail-Pinnacle). All patients underwent whole blood metal ion sampling. Patients were divided into those with ARMD (revised for ARMD or ARMD on imaging; n=75), and those without ARMD (n=635). Previously devised implant-specific blood metal ion thresholds (cobalt=2.15μg/l for unilateral BHR; maximum cobalt or chromium=5.5μg/l for bilateral BHR; cobalt=3.57μg/l for unilateral Corail-Pinnacle) were applied to the validation cohort, with receiver operating characteristic curve analysis used to establish the discriminatory characteristics for each respective threshold. The area under the curve, sensitivity, specificity, positive predictive value and negative predictive value for distinguishing between patients with and without ARMD for each implant-specific threshold were respectively: unilateral BHR=89.4% (95% CI=82.8%-96.0%), 78.9%, 86.7%, 44.1%, 96.9%; bilateral BHR=89.2% (95% CI=81.3%-97.1%), 70.6%, 86.8%, 54.5%, 93.0%; unilateral Corail-Pinnacle=76.9% (95% CI=63.9%-90.0%), 65.0%, 85.4%, 24.5%, 97.1%. The 7μg/l UK MHRA threshold missed significantly more patients with ARMD compared with the implant-specific thresholds (4.9% vs. 2.8%; p=0.0003). This external multi-centre validation study has confirmed that MoM hip arthroplasty patients with blood metal ion levels below newly devised implant-specific thresholds have a low-risk of ARMD. Compared to implant-specific thresholds, the currently proposed fixed MHRA threshold missed more patients with ARMD. We recommend using implant-specific thresholds over fixed thresholds when managing MoM hip arthroplasty patients

Recent studies have reported on non-metal-on-metal hip arthroplasty (non-MoMHA) patients requiring revision surgery for adverse reactions to metal debris (ARMD). Although the outcomes following revision surgery for ARMD in MoMHA patients are known to generally be poor, little evidence exists regarding outcomes following non-MoMHA revision surgery performed for ARMD. We determined the outcomes following non-MoMHA revision surgery performed for ARMD, and identified predictors of re-revision. We performed a retrospective observational study using data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. All primary non-MoMHA patients who subsequently underwent revision surgery for ARMD between 2008–2014 were included (n=185). Outcome measures following ARMD revision were intraoperative complications, mortality, and re-revision surgery. Predictors of re-revision surgery were identified using Cox regression analysis. Intra-operative complications occurred in 6.0% (n=11) of ARMD revisions. The cumulative 4-year patient survival rate was 98.2% (95% CI=92.9–99.5%). Re-revision surgery was performed in 13.5% (n=25) of hips at a mean time of 1.2 years (range 0.1–3.1 years) following ARMD revision. Infection (32%), dislocation/subluxation (24%), and aseptic loosening (24%) were the commonest re-revision indications. The cumulative 4-year implant survival rate was 83.8% (95% CI=76.7%-88.9%). Significant predictors of re-revision were: multiple revision indications (Hazard Ratio (HR)=2.78; 95% CI=1.03–7.49; p=0.043), incomplete revision procedures (including modular component exchange only) (HR=5.76; 95% CI=1.28–25.9; p=0.022), and ceramic-on-polyethylene revision bearings (HR=3.08; 95% CI=1.01–9.36; p=0.047). Non-MoMHA patients undergoing ARMD revision have a high short-term risk of re-revision. Infection, dislocation/subluxation, and aseptic loosening were the commonest re-revision indications. Furthermore, important and potentially modifiable predictors of future re-revision were identified. Although the poor prognostic factors identified require validation in future studies, our findings may be used to counsel patients about the risks associated with ARMD revision surgery, and guide decisions about the reconstructive procedure

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

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

Serum and blood cobalt (Co) and chromium (Cr) ion levels are used to monitor patients at risk for adverse reaction to metal debris (ARMD) following metal-on-metal (MoM) total hip arthroplasty (THA). However, these levels often do not correlate with the degree of local soft-tissue reaction and damage observed at the time of revision. The purpose of this study was to analyze synovial fluid metal ion concentrations in patients with a failed THA in the setting of an ARMD and determine if these levels can be more predictive of soft-tissue destruction than serum or whole blood levels. Synovial, blood and serum samples were prospectively collected from patients undergoing revision THA with ARMD (n=29) and those undergoing aseptic revision without ARMD (n=29). There was no difference in mean age (P=0.50), BMI (P=0.18), sex distribution (P=0.18), serum creatinine (P=0.74), or time to revision THA (P=0.13) between the cohorts. In the AMRD cohort, the components included MoM THA (n=18), hip resurfacing (n=5), dual-modular taper THA (n=4) and MoM and dual-modular taper THA (n=2). At the time of revision THA, 26 (90%) patients in the metal reaction cohort had gross evidence of metallosis in the soft-tissues, the remaining 3 (10%) had evidence of corrosion of the dual taper neck or MoM bearing. In the non ARMD cohort the bearing surfaces included metal-on-polyethylene (n=19) and ceramic-on-polyethylene (n=10). The indications for revision included isolated acetabular loosening (n=11), isolated femoral component loosening (n=11), polyethylene wear (n=5), recurrent dislocation (n=1) and combined femoral and acetabular component loosening (n=1). None had a clinical diagnosis or gross evidence of taper corrosion. Pre-revision, 21 (72%) patients in the metal reaction group had periarticular fluid collections or a mass on MRI. Mean cyst size was 202.9±71.6 cm3 and masses were grouped into Type I (cyst wall <3 mm, n=10), Type II (cyst wall ≥3 mm, n=8) and Type III (mainly solid, n=3). At the time of revision THA, the mean Co levels were elevated in patients with ARMD compared to those without in synovial fluid (1,833 ppb vs. 12.3 ppb, P=0.008), whole blood (22.6 ppb vs 0.5 ppb, P=0.005)) and serum (19.6 vs. 0.6, P=0.001). Likewise, mean Cr levels were significantly elevated in patients with an ARMD compared to those undergoing revision without in synovial fluid (3,128 ppb vs. 10.3 ppb, P=0.01), whole blood (8.9 ppb vs. 0.5 ppb, P=0.009) and serum (14.1 ppb vs. 0.5 ppb, P=0.005). The synovial fluid Co levels were the most accurate test for detecting pseudotumor (AUC 0.951) and adverse local tissue reaction (AUC 0.826). At a synovial fluid Cr level of 110 ppb, the synovial fluid metal ion analysis was 94% sensitive and 86% specific for pseudotumor formation. In this prospective study, synovial fluid analysis of metal ion levels was more accurate in predicting the presence and extent of pseudo-tumor or ALTR compared to blood or serum analysis. The addition of synovial aspiration with metal ion analysis may provide another helpful data point when risk stratifying these patients for need for revision THA

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