Knee Flexionater to Avoid Motion Restoring Surgery

Recruiting now · Not applicable

Conditions studied: Joint Contractures, Total Knee Anthroplasty, Knee Arthrofibrosis

In brief

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery. Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement. This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure? Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home. Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests. Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Key facts

Study ID

NCT07454356

Run by

Ermi LLC

People needed

150

Starts

2025-12-09

Expected to finish

2029-12-01

Last updated by the study team

2026-03-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 40 years or older
• Undergoing primary total knee replacement surgery
• Knee flexion less than 105 degrees at approximately 4 weeks after surgery
• Considered a candidate for motion-restoring surgery, with any surgery delayed until after 2 months of nonoperative treatment

You may not qualify if…

• Not willing to participate
• Diagnosis of advanced rheumatoid arthritis
• Neurological deficit affecting the operative leg
• Revision total knee replacement or previous major surgery on the same knee
• Cognitive impairment
• Prior total hip replacement on the same side (ipsilateral total hip arthroplasty)
• Living more than 2 hours from the study site or unwilling to attend required local physical therapy visits

Where it is running

• INOV8 Orthopedics — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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