Study of StimRouter for Chronic Knee OA Pain (NCT05644639) | Clinical Trial Compass
CompletedNot Applicable
Study of StimRouter for Chronic Knee OA Pain
United States13 participantsStarted 2022-10-18
Plain-language summary
The goal of this study is to evaluate the use of StimRouter Neuromodulation System (StimRouter) in adult subjects with an established diagnosis of primary femorotibial osteoarthritis in the target knee (Kellgren-Lawrence ≥1) who have surgical contraindications to undergo a knee joint arthroplasty procedure. The main questions it aims to answer are:
1. To assess the effect of the StimRouter Neuromodulation System to manage joint pain in patients with symptomatic OA of the knee who are surgically contraindicated to undergo a knee joint arthroplasty
2. To assess the effect of StimRouter on joint stiffness, function and patient quality of life
Participants will have StimRouter leads implanted then clinic visits will be scheduled for follow-up at Week 2, Month 3 and Month 6 (End of Study (EOS) or Early Termination (ET)).
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Subject is at least 21 years of age at the time of giving informed consent
✓. Radiographic disease Stage ≥ 1 in the target knee according to the Kellgren-Lawrence grading of knee OA
✓. Knee joint arthroplasty procedure is contraindicated
✓. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
✓. Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Exclusion criteria
✕. Subject has undergone previous joint arthroplasty procedure (partial, total, patella-femoral) to the index knee
✕. Unresolved effusion of the target knee clinically requiring aspiration within 12 weeks prior to Visit 1 (Baseline)
✕. Treatment of the index knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 6 weeks prior to Visit 1 (Baseline)
What they're measuring
1
Knee Pain
Timeframe: The primary endpoint is at Month 3 post permanent implantation.
2
Knee Pain
Timeframe: The primary endpoint is at Month 3 post permanent implantation.
. Visco-supplementation (e.g., hyaluronic acid) in the index knee within 6 weeks prior to Visit 1 (Baseline)
✕. Subject has an active systemic infection or an active local infection in or near the index knee joint, or has a previous history of joint infection.
✕. Subject with bleeding disorders or active anticoagulation that cannot be stopped for a few days prior to the time of the surgical procedure.
✕. Subject who has an active or existing skin disorder or irritation, which, in the opinion of the Investigator, precludes the use of skin gel electrodes.
✕. Subjects has or plans to have a pacemaker, defibrillator, cochlear implant, and/or a sleep apnea implant.