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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.
Official title: 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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-02-13
Completion Date
2030-06-30
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
MISHA Knee System
The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.
Non-Surgical Treatment
The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.
Locations (8)
UC Davis Department of Orthopaedic Surgery
Davis, California, United States
Scripps Clinic Jefferson
Oceanside, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Genesis Orthopedics & Sports Medicine
Oak Brook, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
Ohio State Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
UT Health San Antonio
San Antonio, Texas, United States