MOTION Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MISHA Knee System, Non-Surgical Treatment.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- WOMAC Pain at 6 Months [Time frame: 6 Months]
Secondary outcome measures (1)
- WOMAC Function at 6 Months [Time frame: 6 Months]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- UC Davis Department of Orthopaedic Surgery — Davis
- Scripps Clinic Jefferson — Oceanside
- Sutter Health — Sacramento
- Rush University Medical Center — Chicago
- Genesis Orthopedics & Sports Medicine — Oak Brook
- University of Nebraska Medical Center — Omaha
- NYU Langone Health — New York
- Ohio State Jameson Crane Sports Medicine Institute — Columbus
- … and 1 more center
Identifiers
NCT: NCT06843980 · CP0011