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. 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.Introduction
Methods
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. 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.Introduction
Patients and Methods
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.
To determine ten-year failure rates following 36 mm metal-on-metal
(MoM) Pinnacle total hip arthroplasty (THA), and identify predictors
of failure. We retrospectively assessed a single-centre cohort of 569 primary
36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012
according to Medicines and Healthcare Products Regulation Agency
recommendations. All-cause failure rates (all-cause revision, and
non-revised cross-sectional imaging failures) were calculated, with predictors
for failure identified using multivariable Cox regression.Aims
Patients and Methods
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). 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.Aims
Patients and Methods
We investigated whether blood metal ions could effectively identify bilateral metal-on-metal hip patients at risk of adverse reactions to metal debris (ARMD). 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).Introduction
Patients and methods
