NCT07454356 Knee Flexionater to Avoid Motion Restoring Surgery
| NCT ID | NCT07454356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ermi LLC |
| Condition | Joint Contractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-12-09 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Shaun K Stinton, PhD
STUDY DIRECTOR
Ermi LLC
Frequently Asked Questions
Who can join the NCT07454356 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Joint Contractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454356 currently recruiting?
Yes, NCT07454356 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ermi LLC to inquire about joining.
Where is the NCT07454356 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07454356 clinical trial?
NCT07454356 is sponsored by Ermi LLC. The principal investigator is Shaun K Stinton, PhD at Ermi LLC. The trial plans to enroll 150 participants.