Comparing a new knee treatment to non-surgical options for knee osteoarthritis

Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis Versus the Use of Non-surgical Treatment: Randomized Clinical Trial and Comparison of Therapies for Medial Knee Osteoarthritis

This study is testing a new knee treatment called the MISHA Knee System to see if it helps people with knee osteoarthritis feel better compared to standard non-surgical options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Moximed (Industry-sponsored)
• Locations: 8 sites (Davis, California and 7 other locations)
• Trial ID: NCT06843980 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, multicenter, two-arm randomized controlled trial that aims to compare the effectiveness of the MISHA Knee System against non-surgical treatments in patients suffering from medial knee osteoarthritis. Participants will be randomly assigned to receive either the MISHA Knee System or standard non-surgical treatment, with outcomes measured to determine which approach provides better relief from knee pain. This is the first head-to-head study specifically evaluating the MISHA Knee System in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals experiencing knee pain localized to the medial compartment who have not found relief from non-surgical treatments.

Not a fit: Patients with significant knee structural issues, such as large osteophytes or poor bone quality, may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option that significantly alleviates knee pain for patients with medial knee osteoarthritis.

How similar studies have performed: This approach is novel as it is the first randomized study comparing the MISHA Knee System directly with non-surgical treatments.

Eligibility criteria

Key Inclusion Criteria:

1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
2. WOMAC pain ≥ 40
3. Failed to find relief in non-surgical treatment modalities

Key Exclusion Criteria:

1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
3. Ligamentous instability
4. Active or recent knee infection
5. Inflammatory joint disease, including sequelae of viral infections
6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
7. History of keloid, hypertrophic or contracture scaring
8. Propensity for restrictive scar formation or adhesions with prior procedures

Where this trial is running

Davis, California and 7 other locations

• UC Davis Department of Orthopaedic Surgery — Davis, California, United States (Recruiting)
• Scripps Clinic Jefferson — Oceanside, California, United States (Recruiting)
• Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
• Genesis Orthopedics & Sports Medicine — Oak Brook, Illinois, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• Ohio State Jameson Crane Sports Medicine Institute — Columbus, Ohio, United States (Recruiting)
• UT Health San Antonio — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Rose S Weinstein

Conditions Osteoarthritis, Knee