A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

What this Trial Is About

Researchers are evaluating different rehabilitation methods following total knee arthroplasty (TKA) in adults aged 18 and older who are patients at hip/knee clinics and scheduled for unilateral primary TKA. The study aims to compare the current standard outpatient physical therapy with a new wearable smart knee brace (FM2 Knee Brace) to see if the brace is a noninferior alternative for recovery after TKA. Participants will be randomly assigned to one of two groups. The first group will follow a routine six-week outpatient physical therapy program, starting as soon as possible after hospital discharge and excluding pool exercises. The second group will use the FM2 Knee Brace device, which is set up at the pre-operative visit, and complete 3-4 prescribed exercises at their own pace over six weeks. Both groups will be monitored during the study. Participants will be assessed before surgery and at 6 weeks, 3 months, and 1 year after surgery. Measurements will include knee flexion, extension, and total arc of motion. Additional data collected will include patient-reported outcomes, therapy adherence, and any complications. The study will last through these follow-up visits to track recovery progress and compare the two rehabilitation approaches.

A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy