MISHA Post-Market Clinical Study

NCT06118892 | Recruiting FDA Device

• 1 other identifier: CP0009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Freedom from device- and procedure-related Subsequent Surgical Interventions

  5 years post-implantation

Secondary Outcomes (2)

• WOMAC Pain

  5 years

• WOMAC Function

  5 years

Study Arms (1)

MISHA Knee System

EXPERIMENTAL

Device: MISHA Knee System

Interventions

MISHA Knee System DEVICE

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.

Also known as: Implantable Shock Absorber (ISA)

MISHA Knee System

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 sequalae 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

Sponsors & Collaborators

• Moximed: lead

Study Sites (3)

Weiss Orthopedics

Sonoma, California, 95476, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Study Officials

• Dennis Crawford, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Weinstein

CONTACT

(510) 887 3375; rsweinstein@moximed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)