Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06843980

MOTION Clinical Trial

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Department of Orthopaedic Surgery, Davis, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

MISHA Knee System

Device

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

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rose S Weinstein

CONTACT

[email protected]

(510) 887 3375

Sponsors and collaborators

Lead sponsor

Moximed

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Feb 25, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.