Actively Recruiting

Phase 4
Age: 18Years - 55Years
All Genders
NCT06311513

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Led by Hospital for Special Surgery, New York · Updated on 2025-11-20

40

Participants Needed

2

Research Sites

253 weeks

Total Duration

On this page

Sponsors

H

Hospital for Special Surgery, New York

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 55 years
  • Previous unilateral ACL reconstruction within the last 5 years with failure of the primary ACLR
  • Scheduled for revision ACL reconstruction surgery with any graft type
  • Able to complete all study procedures and participate in a standardized physical therapy program
Not Eligible

You will not qualify if you...

  • History of inflammatory arthritis or joint infection
  • Prior or current total or sub-total meniscectomy
  • Prior or present avascular necrosis of the index knee
  • Corticosteroid injection (oral or intra-articular) within 3 months
  • Hyaluronic acid or 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 that may compromise safety
  • Planned knee arthroplasty on the index knee

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States, 30097

Actively Recruiting

2

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

D

Daniel de la Huerta, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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