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Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Sponsor: Hospital for Special Surgery, New York
Summary
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)
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-01-22
Completion Date
2028-12
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Concentrated Bone Marrow Aspirate Injection
Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.
Sham Incision
A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.
Revision Anterior Cruciate Ligament Reconstruction
This is the standard-of-care surgical procedure.
Locations (2)
Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States
Hospital for Special Surgery
New York, New York, United States