RECRUITING

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

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 goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Official Title

Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate (cBMA) as a Treatment to Modify Post-Traumatic Osteoarthritis (PTOA) Following Revision Anterior Cruciate Ligament Reconstruction (ACLR)

Quick Facts

Study Start:2024-01-22
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06311513

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 to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females
  2. * Age 18 to 55
  3. * Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR
  4. * Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft)
  5. * Able to complete all study procedures and participate in a standardized physical therapy program
  1. * History of inflammatory arthritis or joint sepsis
  2. * Prior or concurrent total or sub-total meniscectomy
  3. * Prior or present avascular necrosis of the index knee
  4. * Oral or intra-articular corticosteroid injection within 3 months
  5. * Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months
  6. * Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months)
  7. * Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety.
  8. * Planned arthroplasty in the index knee

Contacts and Locations

Study Contact

Daniel de la Huerta, MD
CONTACT
917-260-3159
delahuertamezad@hss.edu

Principal Investigator

Miguel Otero, Ph.D.
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Emory Orthopaedics & Spine Center
Atlanta, Georgia, 30097
United States
Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Miguel Otero, Ph.D., PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

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 Date2024-01-22
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Regenerative Medicine
  • Orthobiologics
  • Concentrated Bone Marrow Aspirate
  • Revision ACLR

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injuries
  • Post-Traumatic Osteoarthritis of Knee
  • Bone Marrow Aspirate Concentrate
  • ACL Injury