Do you have knee pain?

MISHA Knee System

a study on Osteoarthritis

Summary

Location
at Davis, California and other locations
Dates
study started
study ends around
Principal Investigator
by Cassandra Lee, MD

Description

Summary

Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment.

This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.

Official Title

Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis Versus the Use of Non-surgical Treatment: Randomized Clinical Trial and Comparison of Therapies for Medial Knee Osteoarthritis

Keywords

Osteoarthritis, Knee, Knee Osteoarthritis, MISHA Knee System, Non-Surgical Treatment

Eligibility

You can join if…

  1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
  2. WOMAC pain ≥ 40
  3. Failed to find relief in non-surgical treatment modalities

You CAN'T join if...

  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 sequelae 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

Locations

  • UC Davis Department of Orthopaedic Surgery accepting new patients
    Davis California 95816 United States
  • Scripps Clinic Jefferson accepting new patients
    Oceanside California 92054 United States

Lead Scientist at UC Davis

  • Cassandra Lee, MD
    Professor, MED: Orthopaedic Surgery, School of Medicine. Authored (or co-authored) 49 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Moximed
Links
Sign up for this study
ID
NCT06843980
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial