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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hydraulic high Intensity Stretch Device
DeviceA 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 four weeks postoperatively and continue for up to eight weeks, consistent with the study protocol. Participants will receive in-person instruction on device setup and operation and will record frequency and duration of use in a log. Compliance will be monitored through weekly check-ins.
Standard Physical Therapy
Other interventionSupervised 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Physical Therapy OnlyActive comparator 1 intervention
Group B: Hydraulic high-Intensity Stretch Device Plus Standard Physical TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Enrollment in Active and Passive Knee Flexion Range of Motion (Degrees)
Change in active and passive knee flexion measured in degrees using a standard goniometer. Higher values indicate greater knee flexion and improved range of motion.
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-operativeSecondary outcomes
1
Change from Enrollment in KOOS Score
Change in Knee injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. Higher scores indicate better knee function.
Time frame
Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative2
Change from Enrollment in WOMAC Score
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total scores range from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation.
Time frame
Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative3
Change from Enrollment in Visual Analog Scale (VAS) Pain Score
Change in self-reported pain measured using a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain. Lower scores indicate less pain.
Time frame
Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative4
Change from Enrollment in Timed Up and Go (TUG) Test Time (Seconds)
Change in time required to complete the Timed Up and Go test. Lower times (seconds) indicate improved mobility.
Time frame
Baseline (Enrollment), 8 weeks, 12 weeks, 6 months, 1 year, and 2 years post-operative Source ClinicalTrials.gov