NCT06843980NARecruiting
MOTION Clinical Trial
Moximed
Start Date
2/13/2025
Completion Date
6/30/2030
Summary
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.
Eligibility Criteria
Age Range: No minimum to No maximum
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
Interventions
DEVICE
MISHA Knee System
OTHER
Non-Surgical Treatment
Conditions
Osteoarthritis, Knee
Locations
UC Davis Department of Orthopaedic Surgery
Davis, California 95816
United States
Scripps Clinic Jefferson
Oceanside, California 92054
United States
Sutter Health
Sacramento, California 95816
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Genesis Orthopedics & Sports Medicine
Oak Brook, Illinois 60523
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
NYU Langone Health
New York, New York 10016
United States
Ohio State Jameson Crane Sports Medicine Institute
Columbus, Ohio 43202
United States
UT Health San Antonio
San Antonio, Texas 78249
United States