RecruitingPhase 4NCT06311513

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)


Sponsor

Hospital for Special Surgery, New York

Enrollment

40 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Concentrated Bone Marrow Aspirate Injection, a procedure called Revision Anterior Cruciate Ligament Reconstruction, and others for people with acl injury, anterior cruciate ligament injuries, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALConcentrated 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.

PROCEDURESham Incision

A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.

PROCEDURERevision 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

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NCT06311513


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