Blood metal ions have been widely used to investigate metal-on-metal hip replacements, but their ability to discriminate between well-functioning and failed hips is not known. The Medicines and Healthcare products Regulatory Agency (MHRA) has suggested a cut-off level of 7 parts per billion (ppb). We performed a pair-matched, case-control study to investigate the sensitivity and specificity of blood metal ion levels for diagnosing failure in 176 patients with a unilateral metal-on-metal hip replacement. We recruited 88 cases with a pre-revision, unexplained failed hip and an equal number of matching controls with a well-functioning hip. We investigated the 7 ppb cut-off level for the maximum of cobalt or chromium and determined optimal mathematical cut-off levels from receiver-operating characteristic curves. The 7 ppb cut-off level for the maximum of cobalt or chromium had a specificity of 89% and sensitivity 52% for detecting a pre-operative unexplained failed metal on metal hip replacement. The optimal cut-off level for the maximum of cobalt or chromium was 4.97 ppb and had sensitivity 63% and specificity 86%. Blood metal ions had good discriminant ability to separate failed from well-functioning hip replacements. The MHRA cut-off level of 7 ppb provides a specific test but has poor sensitivity.
We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty. MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55 degrees and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of blood metal ions tended to be higher in painful compared with well-functioning metal-on-metal hips. These three clinically useful investigations can help to determine the cause of failure of the implant, predict the need for future revision and aid the choice of revision prostheses.
A periprosthetic cystic pseudotumor was diagnosed commonly (in thirty-four [59%] of the entire study cohort) with use of metal artifact reduction sequence (MARS) magnetic resonance imaging in this series of patients with a metal-on-metal hip prosthesis. The prevalence of pseudotumors was similar in patients with a well-functioning hip prosthesis and patients with a painful hip. Pseudotumors were also diagnosed commonly in patients with a well-positioned acetabular component. Although magnetic resonance imaging is useful for surgical planning, the presence of a cystic pseudotumor may not necessarily indicate the need for revision arthroplasty. Further correlation of clinical and imaging data is needed to determine the natural history of pseudotumors to guide clinical practice.
Background and purpose Operative findings during revision of metal-on-metal hip arthroplasty (MOMHA) vary widely and can involve massive soft tissue and bone disruption. As a result, planning of theater time and resources is difficult, surgery is challenging, and outcomes are often poor. We describe our experience with revision of MOMHA and provide recommendations for management.Patients and methods We present the findings and outcomes of 39 consecutive MOMHAs (in 35 patients) revised in a tertiary unit (median follow-up time 30 (12–54) months). The patients underwent a preoperative work-up including CT, metal artifact reduction sequence (MARS) MRI, and blood metal ion levels.Results We determined 5 categories of failure. 8 of 39 hips had conventional failure mechanisms including infection and impingement. Of the other 31 hips, 14 showed synovitis without significant disruption of soft tissue; 6 had a cystic pseudotumor with significant soft tissue disruption; 7 had significant osteolysis; and 4 had a solid pseudotumor. Each category of failure had specific surgical hazards that could be addressed preoperatively. There were 2 reoperations and 1 patient (2 hips) died of an unrelated cause. Median Oxford hip score (OHS) was 37 (9–48); median change (ΔOHS) was 17 (–10 to 41) points. ΔOHS was similar in all groups—except those patients with solid pseudotumors and those revised to metal-on-metal bearings, who fared worse.Interpretation Planning in revision MOMHA is aided by knowledge of the different categories of failure to enable choice of appropriate personnel, theater time, and equipment. With this knowledge, satisfactory outcomes can be achieved in revision of metal-on-metal hip arthroplasty.
Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67 045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data.Cite this article: Bone Joint J 2015;97-B:10–18.
Background and purposeMetal artifact reduction sequence (MARS) MRI and ultrasound scanning (USS) can both be used to detect pseudotumors, abductor muscle atrophy, and tendinous pathology in patients with painful metal-on-metal (MOM) hip arthroplasty. We wanted to determine the diagnostic test characteristics of USS using MARS MRI as a reference for detection of pseudotumors and muscle atrophy.Patients and methodsWe performed a prospective cohort study to compare MARS MRI and USS findings in 19 consecutive patients with unilateral MOM hips. Protocolized USS was performed by consultant musculoskeletal radiologists who were blinded regarding clinical details. Reports were independently compared with MARS MRI, the imaging gold standard, to calculate predictive values.ResultsThe prevalence of pseudotumors on MARS MRI was 68% (95% CI: 43–87) and on USS it was 53% (CI: 29–76). The sensitivity of USS in detecting pseudotumors was 69% (CI 39–91) and the specificity was 83% (CI: 36–97). The sensitivity of detection of abductor muscle atrophy was 47% (CI: 24–71). In addition, joint effusion was detected in 10 cases by USS and none were seen by MARS MRI.InterpretationWe found a poor agreement between USS and MARS MRI. USS was inferior to MARS MRI for detection of pseudotumors and muscle atrophy, but it was superior for detection of joint effusion and tendinous pathologies. MARS MRI is more advantageous than USS for practical reasons, including preoperative planning and longitudinal comparison.
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