Knee Flexionater to Avoid Motion Restoring Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorErmi LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Hydraulic high Intensity Stretch Device
  • Standard Physical Therapy

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators