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NCT Number: NCT06118892

MISHA Post-Market Clinical Study

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.

Recruiting

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Key information

Conditions

Osteo Arthritis Knee

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weiss Orthopedics, Sonoma, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Implantable Shock Absorber (ISA)

Primary outcomes

  1. Freedom from device- and procedure-related Subsequent Surgical Interventions

    Time frame: 5 years post-implantation

Secondary outcomes

  1. WOMAC Pain

    Time frame: 5 years

    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.

  2. WOMAC Function

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rose Weinstein

CONTACT

[email protected]

(510) 887 3375

Sponsors and collaborators

Lead sponsor

Moximed

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Nov 7, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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