Complications and re-revisions after revisions of 528 metal-on-metal hips because of adverse reaction to metal debris (original) (raw)
Related papers
The Journal of Arthroplasty
Background: Surgeons currently have difficulty when managing metal-on-metal hip arthroplasty (MoMHA) patients with adverse reactions to metal debris (ARMD). This stems from a lack of evidence, which is emphasized by the variability in the recommendations proposed by different worldwide regulatory authorities for considering MoMHA revision surgery. We investigated predictors of poor outcomes following MoMHA revision surgery performed for ARMD to help inform the revision threshold and type of reconstruction. Methods: We retrospectively studied 346 MoMHA revisions for ARMD performed at 2 European centers. Preoperative (metal ions/imaging) and intraoperative (findings, components removed/implanted) factors were used to predict poor outcomes. Poor outcomes were postoperative complications (including rerevision), 90-day mortality, and poor Oxford Hip Score. Results: Poor outcomes occurred in 38.5%. Shorter time (under 4 years) to revision surgery was the only preoperative predictor of poor outcomes (odds ratio [OR] ¼ 2.12, confidence interval [CI] ¼ 1.00-4.46). Prerevision metal ions and imaging did not influence outcomes. Single-component revisions (vs allcomponent revisions) increased the risk of poor outcomes (OR ¼ 2.99, CI ¼ 1.50-5.97). Intraoperative modifiable factors reducing the risk of poor outcomes included the posterior approach (OR ¼ 0.22, CI ¼ 0.10-0.49), revision head sizes 36 mm (vs <36 mm: OR ¼ 0.37, CI ¼ 0.18-0.77), ceramic-on-polyethylene revision bearings (OR vs ceramic-on-ceramic ¼ 0.30, CI ¼ 0.14-0.66), and metal-on-polyethylene revision bearings (OR vs ceramic-on-ceramic ¼ 0.37, CI ¼ 0.17-0.83). Conclusion: No threshold exists for recommending revision in MoMHA patients with ARMD. However postrevision outcomes were surgeon modifiable. Optimal outcomes may be achieved if surgeons use the posterior approach, revise all MoMHA components, and use 36 mm ceramic-on-polyethylene or metalon-polyethylene articulations.
The bone & joint journal, 2014
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 equiv...
Management of metal-on-metal hip implant patients: Who, when and how to revise?
World Journal of Orthopedics, 2016
on-metal (MOM) hip implants continues. With over 1 million patients affected worldwide, the impact is far reaching. The majority of the aggressive failures of MOM hip implants have been dealt with by revision hip surgery, leaving patients with a much more indolent pattern of failure of devices that have been in situ for more than 10 years. The longer-term outcome for such patients remains unknown, and much debate exists on how best to manage these patients. Regulatory guidance is available but remains open to interpretation due to the lack of current evidence and long-term studies. Metal ion thresholds for concern have been suggested at 7 ppb for hip resurfacing arthroplasty and below this level for large diameter total hip arthroplasties. Soft tissue changes including pseudotumours and muscle atrophy have been shown to progress, but this is not consistent. New advanced imaging techniques are helping to diagnose complications with metal hips and the reasons for failure, however these are not widely available. This has led to some centres to tackle difficult cases through multidisciplinary collaboration, for both surgical management decisions and also follow-up decisions. We summarise current evidence and consider who is at risk, when revision should be undertaken and how patients should be managed.
Clinical Orthopaedics and Related Research®, 2012
Background The interpretation of metal ion concentrations and their role in clinical management of patients with metal-on-metal implants is still controversial. Questions/Purposes We questioned whether patients undergoing hip resurfacing with no clinical problems could be differentiated from those with clinical (pain, loss of function) and/or radiographic (component malpositioning, migration, bone loss), problems based on metal ion levels, and if there was a threshold metal level that predicted the need for clinical intervention. Furthermore, we asked if patient and implant factors differed between these functional groups. Methods We retrospectively identified 453 unilateral and 139 bilateral patients with ion measurements at minimum followup of 12 months (mean, 4.3 years; range, 1-12.9 years). Patients were designated as well functioning or poorly functioning based on strict criteria. The acceptable upper levels within the well-functioning group were determined from the 75th percentile plus 1.59 interquartile range. The sensitivity and specificity of these levels to predict clinical problems were calculated. Results Well-functioning group ions were lower than the poorly functioning group ion levels. The acceptable upper levels were: chromium (Cr) 4.6 lg/L, cobalt (Co) 4.0 lg/L unilateral and Cr 7.4 lg/L, Co 5.0 lg/L bilateral. The specificity of these levels in predicting poor function was high (95%) and sensitivity was low (25%). There were more males in the well-functioning group and more females and smaller femoral components in the poorly functioning group. Conclusions Metal levels higher than these proposed safe upper limits can predict problems with metal-on-metal resurfacings and are important parameters in the management of at-risk patients. Each author certifies that he or she, or a member of their immediate family, has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request. Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.
What is appropriate surveillance for metal-on-metal hip arthroplasty patients?
Acta orthopaedica, 2017
The unexpected high revision rates of large-diameter (femoral head sizes of 36 mm or greater) metal-on-metal hip arthroplasties (MoMHAs) have led to worldwide regulatory authorities recommending regular surveillance, even for asymptomatic individuals. However, these recommendations are not evidence-based and are very costly. The rapidly evolving evidence base requires an update regarding the investigation and management of MoMHA patients. This article is the first of 2 (the second article in this series will consider the threshold for performing revision, and the outcomes following ARMD revision surgery: Matharu et al., Revision surgery of metal-on-metal hip arthroplasties for adverse reactions to metal debris: A clinical update. Acta Orthop 2018; in press), and considers the various investigative modalities used during surveillance, with specific focus on blood metal ion sampling and cross-sectional imaging. No single investigation can universally be used during MoMHA patient surve...
The effect of a manufacturer recall on the threshold to revise a metal-on-metal hip
International Orthopaedics, 2014
Purpose Management of the unexplained, painful large diameter metal-on-metal (MOM) hip replacement is difficult. Although there are guidelines for surgeons, there is no clear documented evidence describing the overall threshold for revision surgery. The 2010 product recall of the DePuy Articular Surface Replacement (ASR) and subsequent media coverage may have increased patient and surgeon apprehension, resulting in earlier intervention, i.e. at a greater Oxford hip score (OHS) than expected. Our aim was to investigate whether the threshold for revision using known parameters was affected by the ASR recall. These parameters include poor clinical results (persistent pain or mechanical symptoms), pseudotumour or other progressive soft tissue involvement, osteolysis and high or rising metal ion levels. Methods We used our national referral database of MOM hips, which were revised between 2008 and 2012. Once inclusion and exclusion criteria were applied, we identified 240 patients-71 patients in the pre-recall group and 169 patients in the post-recall group. Results The ASR product recall did not seem to affect the threshold for revision of a MOM hip, with no significant difference between the two groups in terms of the functional (median OHS = 17 pre-recall and 20 post-recall; p=0.2109) and radiological (median inclination angle = 50 pre-recall and 48 post-recall; p=0.3221) markers used to guide management. We did however discover that blood metal ion levels were higher in the post-recall group. Conclusion Issue of a product recall did not change the hip function threshold for revision surgery. The decision to revise a metal-on-metal hip is complex and should follow published guidelines, encompassing metal ion measurement and crosssectional imaging where appropriate.
Revision surgery of metal-on-metal hip arthroplasties for adverse reactions to metal debris
Acta orthopaedica, 2018
Background and purpose - The initial outcomes following metal-on-metal hip arthroplasty (MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD) were poor. Furthermore, robust thresholds for performing ARMD revision are lacking. This article is the second of 2. The first article considered the various investigative modalities used during MoMHA patient surveillance (Matharu et al. 2018a ). The present article aims to provide a clinical update regarding ARMD revision surgery in MoMHA patients (hip resurfacing and large-diameter MoM total hip arthroplasty), with specific focus on the threshold for performing ARMD revision, the surgical strategy, and the outcomes following revision. Results and interpretation - The outcomes following ARMD revision surgery appear to have improved with time for several reasons, among them the introduction of regular patient surveillance and lowering of the threshold for performing revision. Furthermore, registry data suggest that ou...
Journal of Bone and Joint Surgery, American Volume, 2016
Background: We investigated whether blood metal ions could effectively identify patients with metal-on-metal hip implants with two common designs (Birmingham Hip Resurfacing [BHR] and Corail-Pinnacle) who were at risk of adverse reactions to metal debris. Methods: This single-center, prospective study involved 598 patients with unilateral hip implants (309 patients with the BHR implant and 289 patients with the Corail-Pinnacle implant) undergoing whole blood metal ion sampling at a mean time of 6.9 years. Patients were classified into two groups, one that had adverse reactions to metal debris (those who had to undergo revision for adverse reactions to metal debris or those with adverse reactions to metal debris on imaging; n = 46) and one that did not (n = 552). Three metal ion parameters (cobalt, chromium, and cobalt-chromium ratio) were compared between groups. Optimal metal ion thresholds for identifying patients with adverse reactions to metal debris were determined using receiver operating characteristic analysis. Results: All ion parameters were significantly higher (p < 0.0001) in the patients who had adverse reactions to metal debris compared with those who did not. Cobalt maximized the area under the curve for patients with the BHR implant (90.5%) and those with the Corail-Pinnacle implant (79.6%). For patients with the BHR implant, the area under the curve for cobalt was significantly greater than that for the cobalt-chromium ratio (p = 0.0005), but it was not significantly greater than that for chromium (p = 0.8483). For the patients with the Corail-Pinnacle implant, the area under the curve for cobalt was significantly greater than that for chromium (p = 0.0004), but it was similar to that for the cobalt-chromium ratio (p = 0.8139). Optimal blood metal ion thresholds for identifying adverse reactions to metal debris varied between the two different implants. When using cobalt, the optimal threshold for identifying adverse reactions to metal debris was 2.15 mg/L for the BHR group and 3.57 mg/L for the Corail-Pinnacle group. These thresholds had good sensitivities (88.5% for the BHR group and 80.0% for the Corail-Pinnacle group) and specificities (84.5% for the BHR group and 76.2% for the Corail-Pinnacle group), high negative predictive values (98.8% for the BHR group and 98.1% for the Corail-Pinnacle group), and low positive predictive values (34.3% for the BHR group and 20.0% for the Corail-Pinnacle group). The authority thresholds proposed by the United States continued Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
The bone & joint journal, 2016
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