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MISHA Post-Market Clinical Study

Moximed · NCT06118892

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 25–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
4
Study start
November 3, 2023
Record last updated
July 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: MISHA Knee System

Conditions: Osteo Arthritis Knee

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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

Key Exclusion Criteria

  • 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

Recruiting US locations

  • Weiss Orthopedics

    Sonoma, CA 95476

    Site contact: Noah Weiss

  • Orthopaedics Specialists of NC

    Raleigh, NC 27614

    Site contact: Mark Galland, MD

  • Oregon Health and Science University

    Portland, OR 97239

    Site contact: Dennis Crawford, MD

  • University of Virginia

    Charlottesville, VA 22903

    Site contact: David Diduch, MD

Study contacts (from the official record)

  • Rose Weinstein · (510) 887 3375 · rsweinstein@moximed.com
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MISHA Post-Market Clinical Study (NCT06118892) | Bored Studies