MOTION Clinical Trial
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
1 other identifier
interventional
100
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2025
CompletedFirst Submitted
Initial submission to the registry
February 19, 2025
CompletedFirst Posted
Study publicly available on registry
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
ExpectedMay 6, 2026
May 1, 2026
1.2 years
February 19, 2025
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
WOMAC Pain at 6 Months
Improvement in WOMAC Pain in the MISHA arm compared to the non-surgical arm measured on the initial cohort who complete the 6-month follow-up visit
6 Months
Secondary Outcomes (1)
WOMAC Function at 6 Months
6 Months
Study Arms (2)
MISHA Knee System
EXPERIMENTALThe 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
ACTIVE COMPARATORThe non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- Ligamentous instability
- Active or recent knee infection
- Inflammatory joint disease, including sequelae of viral infections
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- History of keloid, hypertrophic or contracture scaring
- Propensity for restrictive scar formation or adhesions with prior procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moximedlead
Study Sites (8)
UC Davis Department of Orthopaedic Surgery
Davis, California, 95816, United States
Scripps Clinic Jefferson
Oceanside, California, 92054, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rose S Weinstein
Moximed
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Randomization is programmed within the Electronic Data Capture system to ensure that the groups are unbiased and that the results are reliable, independent from the participant, investigator, and sponsor. The outcomes assessor remains independent from the participant, investigator and the sponsor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2025
First Posted
February 25, 2025
Study Start
February 13, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 30, 2030
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share