Recruiting

MISHA™

Sponsor:

Moximed

Code:

NCT06843980

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MISHA Knee System

Non-Surgical Treatment

Study Details

Brief 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

Osteoarthritis, Knee

Study ID

NCT06843980

Start date

Feb 13, 2025

Status verified date

Jul, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Apr 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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 measure

  • WOMAC Pain at 6 Months [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Rose S Weinstein

(510) 887 3375rsweinstein@moximed.com

Locations

Scripps Clinic Jefferson

Recruiting

Oceanside, California, United States, 92054

Principal Investigator:

Tianyi Wang, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Adam B Yanke, MD

Genesis Orthopedics & Sports Medicine

Recruiting

Oak Brook, Illinois, United States, 60523

Principal Investigator:

Hythem Shadid, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Matthew Tao, MD

Ohio State Jameson Crane Sports Medicine Institute

Recruiting

Columbus, Ohio, United States, 43202

Principal Investigator:

Robert Magnussen, MD

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78249

Principal Investigator:

Thomas DeBerardino, MD

More Information

Sponsor

Moximed

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Moximed on 2026-07-14.