RECRUITING

Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

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

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Official Title

Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy

Quick Facts

Study Start:2017-12-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02582489

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is greater than 18 years old
  2. * Written informed consent is obtained
  3. * Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy
  4. * Meniscal pathology is confirmed through MRI and arthroscopically
  5. * Subject agrees to all follow-up evaluations
  6. * Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views
  1. * Any subject lacking decisional capability
  2. * Unwillingness to participate in the necessary follow-up
  3. * Subject is pregnant or may become pregnant
  4. * History of diabetes mellitus
  5. * History of rheumatoid arthritis or other autoimmune disorder
  6. * History of solid organ or hematologic transplantation
  7. * Diagnosis of a non-basal cell malignancy within the preceding 5 years
  8. * Infection requiring antibiotic treatment within the preceding 3 months
  9. * Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
  10. * Prior surgery on the index meniscus
  11. * Concomitant surgery such as ligament surgery or cartilage repair or restoration
  12. * Infection
  13. * Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks

Contacts and Locations

Study Contact

Carla Edwards, PhD
CONTACT
312-563-5735
carla_edwards@rush.edu

Principal Investigator

Brian J Cole, MD, MBA
PRINCIPAL_INVESTIGATOR
Midwest Orthopaedics at Rush

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Brian J Cole, MD, MBA, PRINCIPAL_INVESTIGATOR, Midwest Orthopaedics at Rush

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 Date2017-12-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-12-22
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Mesenchymal stem cells
  • Bone marrow aspirate concentrate

Additional Relevant MeSH Terms

  • Osteoarthritis Post-meniscectomy