Actively Recruiting
Knee Flexionater to Avoid Motion Restoring Surgery
Led by Ermi LLC · Updated on 2026-03-06
150
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Knee Flexionater to Avoid Motion Restoring Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
- Living more than 2 hours from the study site or unwilling to attend required local physical therapy visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
INOV8 Orthopedics
Houston, Texas, United States, 77043
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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