Knee Osteoarthritis Clinical Trial
Official title:
Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System
The main purpose of this study is to record information from clinical and radiographic
examinations and patient assessment questionnaires before surgery and at suitable
postoperative intervals to assess the functioning and symptomology of each knee following
surgery.
In addition, any adverse events or complications are to be recorded, and any device failures
or early revisions are to be recorded and reported directly to the Sponsor. The data are to
be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum
of 5 years.
The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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