Knee Flexionater to Avoid Motion Restoring Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydraulic high Intensity Stretch Device, Standard Physical Therapy.
- Who it may be relevant to
- Registry conditions: Joint Contractures, Total Knee Anthroplasty, Knee Arthrofibrosis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing High Intensity Stretch Device Combined With Physical Therapy Versus Physical Therapy Alone to Prevent Motion-Restoring Surgery Following Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial
Overview
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.
Interventions
- Device Hydraulic high Intensity Stretch Device
A hydraulic high-intensity mechanical stretch device (Ermi Knee Flexionater) used as an adjunct to standard postoperative physical therapy following primary total knee arthroplasty. The device is designed to apply controlled, patient-actuated stretch to increase knee flexion range of motion. Participants assigned to this intervention will use the device at home daily for approximately one hour, in addition to attending prescribed physical therapy sessions. Device use will begin at approximately - Other Standard Physical Therapy
Supervised postoperative physical therapy following primary total knee arthroplasty. Therapy includes range of motion exercises, strengthening, neuromuscular re-education, manual therapy, and functional rehabilitation as determined by the treating clinician.
Primary outcome measures
- Change from Enrollment in Active and Passive Knee Flexion Range of Motion (Degrees) [Time frame: Baseline (Enrollment at 4 weeks post-operative), 8 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative, and 2 years post-operative]
Secondary outcome measures (6)
- Change from Enrollment in KOOS Score [Time frame: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
- Change from Enrollment in WOMAC Score [Time frame: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
- Change from Enrollment in Visual Analog Scale (VAS) Pain Score [Time frame: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
- Change from Enrollment in Timed Up and Go (TUG) Test Time (Seconds) [Time frame: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
- Change from Enrollment in Six-Minute Walk Test (6MWT) Distance (Meters) [Time frame: Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative]
- Number of Participants Experiencing Adverse Events [Time frame: From enrollment to 2 years post-operative follow-up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- INOV8 Orthopedics — Houston
Identifiers
NCT: NCT07454356 · RCT-EF-225