Ceramic on Metal Total Hip Replacement System: A Safety and Efficacy Study

This industry sponsored study will examine the safety and effectiveness of a non-FDA approved total hip replacement device. This device is unique, in that it employs a large ceramic "ball" on a metal "socket" joint, which can potentially reduce metal ion production as compared to metal on metal devices. Approximately 264 subjects will be enrolled in this multicenter study. Subjects will complete surveys as well as radiographic and physical examinations preoperatively and at 3, 6, 12, and 24 months postoperatively. Additionally, there is an optional associated metal ion study that will analysis and monitor the level of metal ions produced by this device. Success of the device will be determined at 24 months postoperatively. The results of this study will be compared to those of a similar study on an FDA approved metal on metal hip replacement device.