Osteoarthritis, Knee Clinical Trial
Official title:
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States. ;
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