Evaluating Biomechanical Footwear as a Non-Invasive Alternative to Total Knee Replacement and as a Post-Surgery Rehabilitation Aid for Knee Osteoarthritis

What this Trial Is About

Osteoarthritis OA of the knee is a common and costly condition that affects millions of adults, often leading to the need for total knee replacement TKR surgery. This study evaluates AposHealth, a non-invasive biomechanical footwear treatment, as both an alternative to TKR for eligible patients and as a supplement to traditional rehabilitation after TKR. The study aims to assess whether this home-based treatment can improve patient outcomes and reduce pain associated with knee OA. Participants will receive AposHealth, which involves wearing specially designed footwear with convex pods that are calibrated by a trained therapist to help reduce knee pain by altering biomechanics. Patients will follow a home-based plan, gradually increasing wear time from 20 to 60 minutes daily. Those undergoing TKR will receive standard surgical care, with post-op patients receiving traditional physical therapy combined with AposHealth starting six weeks after surgery and continuing for 12 months. Follow-up visits occur at 1, 3, 6, 9, and 12 months, with remote checks to ensure adherence and device recalibration. Throughout the study, participants will undergo assessments including pain measurement using the Numerical Pain Rating Scale, physical function surveys, gait analysis, and monitoring of pain medication use. Regular clinical evaluations will adjust treatment as needed, with the primary outcome focusing on pain at 12 months. The total study duration and follow-up extend up to one year, allowing researchers to evaluate both short- and longer-term effects of the AposHealth device on knee OA management and recovery after knee replacement.

Biomechanical Footwear as a Non-invasive Alternative and Supplement to Total Knee Replacement