MOTION Clinical Trial
Recruiting · NCT06843980 · Interventional (participants receive a specific treatment) · Lead sponsor: Moximed
View the official record on ClinicalTrials.gov →Interventions studied
MISHA Knee SystemNon-Surgical Treatment
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
9 locations listed across 6 US states.
- UC Davis Department of Orthopaedic Surgery - Davis, California, United States
- Scripps Clinic Jefferson - Oceanside, California, United States
- Sutter Health - Sacramento, 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