Long-Term Observational Study of LEGION Medial Stabilized Insert for Total Knee Replacement in Arthritis Patients

What this Trial Is About

Researchers are studying the safety and performance of the LEGION Medial Stabilized insert used in total knee arthroplasty TKA for patients with degenerative joint disease such as osteoarthritis, post-traumatic arthritis, or inflammatory arthritis. This observational study includes both prospective and retro-prospective participants and aims to provide long-term evidence to support product registration worldwide. The study involves three groups receiving different LEGION MS insert combinations with tibia and femoral components Cemented CoCr, Cemented Oxinium, and Cementless options. Participants will be followed for 10 years after their primary knee replacement surgery to monitor outcomes related to the implant. During the study, participants will undergo regular assessments including the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement KOOS JR, Oxford Knee Score, Forgotten Joint Score, and EuroQol Five-Dimensional EQ-5D-5L questionnaires at multiple timepoints from 6 weeks up to 10 years post-surgery. Implant survivorship will be tracked at intervals up to 10 years, with all participants consenting to follow-up visits and outcome reporting to evaluate long-term device safety and effectiveness.

A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)