MISHA Post-Market Clinical Study

Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: MISHA Knee System

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rose Weinstein; Phone Number: (510) 887 3375; Email: rsweinstein@moximed.com

Study Locations

• United States
  • California
    • Sonoma, California, United States, 95476
      • Recruiting
      • Weiss Orthopedics
      • Contact: Noah Weiss
      • Principal Investigator: Noah Weiss, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
      • Contact: Dennis Crawford, MD
      • Principal Investigator: Dennis Crawford, MD
      • Sub-Investigator: Samantha Raphael, PA
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Principal Investigator: David Diduch, MD
      • Contact: David Diduch, MD
      • Sub-Investigator: Frank Gwathmey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MISHA Knee System

Device: 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.; Other Names: Implantable Shock Absorber (ISA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from device- and procedure-related Subsequent Surgical Interventions	5 years post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC Pain	Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of pain. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.	5 years
WOMAC Function	Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of function. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.	5 years

Collaborators and Investigators

• Sponsor: Moximed
• Investigators: Principal Investigator: Dennis Crawford, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CP0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No