Identification of implant outliers in joint replacement registries

Abstract

Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.

Keywords: hip replacement; joint registries; knee replacement; outlier prostheses identification; post-market surveillance.