Trials / Recruiting
RecruitingNCT06843980
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Moximed · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-02-13
- Primary completion
- 2026-04-30
- Completion
- 2030-06-30
- First posted
- 2025-02-25
- Last updated
- 2026-01-13
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06843980. Inclusion in this directory is not an endorsement.