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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Activity exacerbated knee pain isolated to the medial compartment and not global in nature
• WOMAC pain ≥ 40
• Failed to find relief in non-surgical treatment modalities
Locations
United States
California
UC Davis Department of Orthopaedic Surgery
RECRUITING
Davis
Scripps Clinic Jefferson
RECRUITING
Oceanside
Illinois
Rush University Medical Center
RECRUITING
Chicago
Genesis Orthopedics & Sports Medicine
RECRUITING
Oak Brook
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
NYU Langone Health
RECRUITING
New York
Ohio
Ohio State Jameson Crane Sports Medicine Institute
RECRUITING
Columbus
Texas
UT Health San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Rose S Weinstein
rsweinstein@moximed.com
4153120255
Backup
Vijaya Krishnamoorthy
vkrishnamoorthy@moximed.com
5108873328
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Moximed