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.

Data on retrieval analysis of current generation metal on metal hip replacements is scarce. Such analysis may help to reduce the incidence of failure and revision procedures. Our aim was to investigate the wear characteristics of explanted (ie failed) metal on metal (MOM) acetabular components in terms of; 1) wear rate; and 2) distribution of the wear (specifically edge loading).

30 hips were collected from 20 centres. The types of prostheses were: 15 BHR; 10 Cormet and 5 ASR. Wear of the acetabular components of the prostheses was measured using an out of roundness (Rondcom 60A) machine. We recorded the implantation and removal date of each hip.

The median linear wear rate was 7.32μm/year; this is at least 3 times greater than steady state wear rates reported for similar components worn in hip simulator studies. For 24 out of 30 cups, the greatest linear wear was recorded at the cup edge.

Failed metal-on-metal acetabular components were associated with higher than expected wear rates. The highest wear was seen closest to the cup edge in the majority of patients suggesting edge loading had occurred and probably explained the high wear rates. Accurate cup placement (to avoid edge loading) may reduce the failure of MOM hips.

Introduction: Approximately 0.5 % of patients with metal on metal hip replacements develop post operative pain which is thought to be due to an immune reaction to metal wear particles, known as Aseptic Lymphocyte Dominated Vasculitis Associated Lesion (ALVAL). Treatment usually requires revision to a non metal on metal hip.. Is the development of ALVAL more likely in those patients with high wear rates?

Methods: Retrieved Metal on Metal (MOM) hip implants; periprosthetic tissue and blood samples were obtained from patients (n = 18) undergoing revision for unexplained pain at a mean of 2 years post operatively. The following variables were measured:

linear wear rate (depth of the femoral head and acetabular socket wear patch/time from operation);

All implants and tissue samples were analysed against control samples from patients undergoing revision of MOM hips for fractured femoral neck or impingement.

Results: Linear wear rates of retrieved implants, and blood levels of cobalt and chromium from patients with unexplained plain were greater than from control patients. Histolopathological analysis of tissue showed dense inflammatory infiltrates with healthy looking endothelial cells in all vessels from both patient groups.

Discussion and Conclusion: A painful MOM hip was associated with high wear rates and blood metal levels. The local inflammatory response was similar to “ALVAL”, ie lymphocyte dominated, but not exclusive to those patients with unexplained pain. We question whether ALVAL represents a vasculitis, or merely a classical lymphocyte driven inflammatory tissue response to metal debris particles.