MISHA Post-Market Clinical Study

Recruiting · NCT06118892 · Interventional (participants receive a specific treatment) · Lead sponsor: Moximed

View the official record on ClinicalTrials.gov →

Interventions studied

MISHA Knee System

What this trial 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.

Who can take part

Age range

25 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

4 locations listed across 4 US states.

Weiss Orthopedics - Sonoma, California, United States
Orthopaedics Specialists of NC - Raleigh, North Carolina, United States
Oregon Health and Science University - Portland, Oregon, United States
University of Virginia - Charlottesville, Virginia, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →