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Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

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)

Who can join

Ages 18 to 55 · All sexes

Inclusion Criteria:

* Males and Females
* Age 18 to 55
* Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR
* Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft)
* Able to complete all study procedures and participate in a standardized physical therapy program

Exclusion Criteria:

* History of inflammatory arthritis or joint sepsis
* Prior or concurrent total or sub-total meniscectomy
* Prior or present avascular necrosis of the index knee
* Oral or intra-articular corticosteroid injection within 3 months
* Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months
* Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months)
* Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety.
* Planned arthroplasty in the index knee

About the study

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.

What is being tested

• Concentrated Bone Marrow Aspirate Injection (biological)
• Sham Incision (procedure)
• Revision Anterior Cruciate Ligament Reconstruction (procedure)

Sponsor: Hospital for Special Surgery, New York · Participants: 40 · Started: Jan 22, 2024

Contact the study team

• Daniel de la Huerta, MD · Phone: 917-260-3159

Official record on ClinicalTrials.gov — NCT06311513

Locations in the U.S.

Conditions

• Anterior Cruciate Ligament Injuries

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.