RecruitingNot ApplicableNCT06843980

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

Sponsor

Moximed

Enrollment

100 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis, Knee

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.

Eligibility

Inclusion Criteria3

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 Criteria8

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

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Interventions

DEVICEMISHA 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.

OTHERNon-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.