MISHA™ Randomized Study

Description

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.

Conditions

Osteoarthritis, Knee

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Study Overview

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Study Details

Study overview

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.

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

MISHA™ Randomized Study

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Columbus

Ohio State Jameson Crane Sports Medicine Institute, Columbus, Ohio, United States, 43202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Moximed,

Rose S Weinstein, STUDY_DIRECTOR, Moximed

Study Record Dates

2029-12-31