RECRUITING

MISHA Post-Market Clinical 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 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.

Official Title

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

Quick Facts

Study Start:2023-11-03
Study Completion:2030-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06118892

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:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects aged 25 to 65 years at time of index procedure
  2. 2. Body Mass Index (BMI) of \< 35
  3. 3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
  4. 4. WOMAC pain ≥ 40
  5. 5. Failed non-operative OA treatment
  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 sequalae 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 Weinstein
CONTACT
5108873375
rsweinstein@moximed.com
Vijaya Krishnamoorthy
CONTACT
5108873328
vkrishnamoorthy@moximed.com

Principal Investigator

Dennis Crawford, MD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Moximed

  • Dennis Crawford, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

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 Date2023-11-03
Study Completion Date2030-07-30

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2030-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Osteo Arthritis Knee