Comparing High Intensity Stretch Device Combined With Physical Therapy Versus Physical Therapy Alone to Prevent Motion-Restoring Surgery Following Primary Total Knee Arthroplasty

What this Trial Is About

Researchers are evaluating whether adding a hydraulic high-intensity stretching device called the Ermi Knee Flexionater to standard physical therapy can help people regain knee bending after total knee replacement surgery. The study focuses on patients who have difficulty bending their knee during recovery and aims to see if the device improves knee movement and affects recovery, daily activities, or the need for additional motion-restoring surgery. Participants are randomly assigned to one of two groups. One group receives standard postoperative physical therapy following their clinician's usual rehabilitation plan. The other group receives the same physical therapy plus uses the Ermi Knee Flexionater device at home daily for about one hour. Device use begins around four weeks after surgery and continues for up to eight weeks. Participants receive instruction on device use and record their compliance in a log, with weekly check-ins from researchers. Participants join the study about four weeks after surgery and have visits at approximately 8 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. Researchers measure how well participants can bend their knee, assess pain and daily function using questionnaires, and perform walking and mobility tests. They track changes over time and monitor any adverse events to compare outcomes between the two groups.

Knee Flexionater to Avoid Motion Restoring Surgery