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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

TypeNameDescription
DEVICEMISHA Knee SystemThe 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.
OTHERNon-Surgical TreatmentThe 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

Source: ClinicalTrials.gov record NCT06843980. Inclusion in this directory is not an endorsement.

MOTION Clinical Trial (NCT06843980) · Clinical Trials Directory