Recruiting

Observational Study

Sponsor:

Moximed

Code:

NCT06118892

Conditions

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

MISHA Knee System

Study Details

Brief summary:

Prospective evaluation of the safety and effectiveness of the MISHA Knee System.

The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.

The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.

This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.

Study subjects will be followed over a five-year post-implant period.

Conditions

Osteo Arthritis Knee

Study ID

NCT06118892

Start date

Nov 3, 2023

Status verified date

Jul, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Subjects aged 25 to 65 years at time of index procedure
2. Body Mass Index (BMI) of < 35
3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
4. WOMAC pain ≥ 40
5. Failed non-operative OA treatment

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 sequalae 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

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MISHA Knee System

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.

Primary outcome measure

  • Freedom from device- and procedure-related Subsequent Surgical Interventions [ Time Frame: 5 years post-implantation ]

Central Contacts and Locations

Central contacts

Rose Weinstein

(510) 887 3375rsweinstein@moximed.com

Locations

Weiss Orthopedics

Recruiting

Sonoma, California, United States, 95476

Principal Investigator:

Noah Weiss, MD

Orthopaedics Specialists of NC

Recruiting

Raleigh, North Carolina, United States, 27614

Principal Investigator:

Mark Galland, MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Dennis Crawford, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

David Diduch, 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 2026-09-10. This information was provided to ClinicalTrials.gov by Moximed on 2026-07-14.