MOTION Clinical Trial

June 2, 2026 updated by: Moximed

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Davis, California, United States, 95816
        • Terminated
        • UC Davis Department of Orthopaedic Surgery
      • Oceanside, California, United States, 92054
        • Recruiting
        • Scripps Clinic Jefferson
        • Principal Investigator:
          • Tianyi Wang, MD
        • Contact:
          • Boyka Petrov
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Sub-Investigator:
          • Brian Cole, MD
        • Principal Investigator:
          • Adam B Yanke, MD
        • Contact:
          • Carla Edwards
      • Oak Brook, Illinois, United States, 60523
        • Recruiting
        • Genesis Orthopedics & Sports Medicine
        • Principal Investigator:
          • Hythem Shadid, MD
        • Contact:
        • Sub-Investigator:
          • Nolan Horner, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Tao, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Alexander Golant, MD
        • Sub-Investigator:
          • Guillem Gonzalez-Lomas, MD
        • Sub-Investigator:
          • Laith Jazrawi, MD
        • Contact:
          • Kobe Rodney
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • Ohio State Jameson Crane Sports Medicine Institute
        • Principal Investigator:
          • Robert Magnussen, M.D.
        • Sub-Investigator:
          • David Flanigan, M.D.
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78249
        • Recruiting
        • UT Health San Antonio
        • Contact:
        • Principal Investigator:
          • Thomas DeBerardino, MD
        • Sub-Investigator:
          • Leah Brown, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Pain at 6 Months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Function at 6 Months
Time Frame: 6 Months
Improvement in WOMAC Function in the MISHA arm to the non-surgical arm measured on the fully enrolled population who complete the 6-month follow-up visit
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moximed

Investigators

  • Study Director: Rose S Weinstein, Moximed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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