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Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

NCT06311513 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Arthritis Foundation

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311513 on ClinicalTrials.gov