RECRUITING

MISHA™ Randomized Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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 Assessment and Comparison of Therapies for Medial Knee Osteoarthritis

Quick Facts

Study Start:2025-02-13
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06843980

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
  2. 2. WOMAC pain ≥ 40
  3. 3. Failed to find relief in non-surgical treatment modalities
  1. 1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
  2. 2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
  3. 3. Ligamentous instability
  4. 4. Active or recent knee infection
  5. 5. Inflammatory joint disease, including sequelae of viral infections
  6. 6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
  7. 7. History of keloid, hypertrophic or contracture scaring
  8. 8. Propensity for restrictive scar formation or adhesions with prior procedures

Contacts and Locations

Study Contact

Rose S Weinstein
CONTACT
4153120255
rsweinstein@moximed.com
Vijaya Krishnamoorthy
CONTACT
5108873328
vkrishnamoorthy@moximed.com

Principal Investigator

Rose S Weinstein
STUDY_DIRECTOR
Moximed

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Moximed

  • Rose S Weinstein, STUDY_DIRECTOR, Moximed

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-02-13
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee