MOTION Clinical Trial

Moximed100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Osteoarthritis, Knee

Interventions

MISHA Knee SystemDEVICE

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.

Non-Surgical TreatmentOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature 2. WOMAC pain ≥ 40 3. Failed to find relief in non-surgical treatment modalities Key Exclusion Criteria: 1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device 2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis) 3. Ligamentous instability 4. Active or recent knee infection 5. Inflammatory joint disease, including sequelae of viral infections 6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals 7. History of keloid, hypertrophic or contracture scaring 8. Propensity for restrictive scar formation or adhesions with prior procedures

Locations (9)

UC Davis Department of Orthopaedic Surgery

Davis, California, United States

TERMINATED

Scripps Clinic Jefferson

Oceanside, California, United States

RECRUITING

Sutter Health

Outcomes

Primary Outcomes

WOMAC Pain at 6 Months

Improvement in WOMAC Pain in the MISHA arm compared to the non-surgical arm measured on the initial cohort who complete the 6-month follow-up visit

Time frame: 6 Months

Secondary Outcomes

WOMAC Function at 6 Months

Improvement in WOMAC Function in the MISHA arm to the non-surgical arm measured on the fully enrolled population who complete the 6-month follow-up visit

Time frame: 6 Months

Central Contacts

Rose S Weinstein

CONTACT

(510) 887 3375 rsweinstein@moximed.com

Data from ClinicalTrials.gov

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