Osteoarthritis Clinical Trial
Official title:
A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.
The primary purpose of this investigation is to evaluate the surgical performance of the
DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a
Multi-centre setting.
The secondary objective of this investigation is to evaluate the long-term survivorship of
the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely
and accurately implant the preservation Unicompartmental Knee using postoperative
radiographic limb and component alignment data.
Secondary endpoints - to demonstrate the survivorship and performance of the Preservation
Unicompartmental Knee using the American Knee Society clinical and radiological assessment,
Oxford Knee Score and survivorship analysis.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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