The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.
A). Prospective Subjects: Subject needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained
Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events
12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events
Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).
Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.
Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.
At the time of surgery, subject has one or more of the following arthroplasties that are not fully healed and/or well-functioning, in the opinion of the Investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; contralateral primary TKA or UKA.
Smith & Nephew, Inc.
Lead sponsor