Stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the REDAPT 15 study.
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.
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Modular stem revision
Timeframe: 5 years post operatively