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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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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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