Condition: Osteoarthritis, Knee · Sponsor: Moximed
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Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.
This description comes directly from the study's public registry record.
Rose S Weinstein · (510) 887 3375 · rsweinstein@moximed.com
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| UC Davis Department of Orthopaedic Surgery | Davis, California, United States | Terminated |
| Scripps Clinic Jefferson | Oceanside, California, United States | Recruiting |
| Sutter Health | Sacramento, California, United States | Active Not 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 | Active Not Recruiting |
| Ohio State Jameson Crane Sports Medicine Institute | Columbus, Ohio, United States | Recruiting |
| UT Health San Antonio | San Antonio, Texas, United States | Recruiting |
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