Osteoarthritis, Knee Clinical Trial
Official title:
A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
PRIMARY ENDPOINT: - The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon SECONDARY ENDPOINTS: The secondary endpoints are to evaluate: - KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment - Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment - Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment - Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery - Survivorship analysis of the device at 12 and 24 months and annually thereafter ;
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