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RECRUITING
NCT06311513
PHASE4

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Sponsor: Hospital for Special Surgery, New York

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

PROCEDURE

Sham Incision

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

PROCEDURE

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