Evaluation of the MISHA Knee System Device for Treating Medial Knee Osteoarthritis in Adults Aged 25 to 65

What this Trial Is About

Researchers are evaluating the MISHA Knee System, a device designed to treat medial knee osteoarthritis in adults aged 25 to 65. This study focuses on assessing the safety and effectiveness of the device over a long-term period, particularly by monitoring device- and procedure-related surgical interventions, pain, function, and satisfaction. The trial aims to provide important information about the devices performance and potential benefits for people with knee osteoarthritis. Participants will receive the MISHA Knee System implant, which is an extra-capsular knee device intended to reduce load on the medial knee. The implant includes an absorber fixed with locking screws to the femur and tibia, designed to share the load with the knee joint while allowing natural motion. The study follows participants for five years post-procedure to assess device function and safety. During the study, participants will attend clinical visits where researchers will evaluate pain and function using WOMAC scores, satisfaction through the Knee Society Score, activity levels, body mass index, knee range of motion, and perform X-ray evaluations. The primary outcome is freedom from device- and procedure-related subsequent surgical interventions at five years. The study will also monitor any conversions to arthroplasty and adverse events related to the device throughout this period.

MISHA Post-Market Clinical Study