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Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

This study is looking at whether concentrated bone marrow aspirate (cBMA) can help improve pain and other symptoms in people who are having a second (revision) surgery for a torn ACL (anterior cruciate ligament) in their knee. cBMA is a product made from your own bone marrow, which is thought to help reduce inflammation and promote healing. You might be able to join if you are between 18 and 55 years old, have had a previous ACL surgery that failed within the last 5 years, and are scheduled for a revision ACL surgery. The main goal is to see if cBMA can reduce knee pain after surgery. The study status is currently unclear, and it plans to enroll 40 participants.

Study design
This is a pilot randomized clinical trial, meaning participants will be randomly assigned to either receive the cBMA injection or a sham (fake) incision during their revision ACL surgery. It plans to enroll 40 participants.
What's involved
You would undergo a revision ACL reconstruction surgery. If assigned to the cBMA group, bone marrow would be harvested from your hip bone during surgery. You would also have follow-up assessments for knee pain at several points after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for knee pain at 6 weeks, 6 months, 12 months, and 24 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06311513

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Recruiting
PHASE4Ages 18–55InterventionalPrevention
Hospital for Special Surgery, New York
~40 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:Concentrated Bone Marrow Aspirate InjectionSham IncisionRevision Anterior Cruciate Ligament Reconstruction

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in patient reported knee pain
Measured over Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Conditions

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

Explore related trials

Injury of anterior cruciate ligamentOsteoarthritis of knee due to and following trauma

NCT06311513

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hospital for Special Surgery

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Emory Orthopaedics & Spine Center

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Daniel de la Huerta, MD
[email protected]
917-260-3159
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline in patient reported knee painBaseline, 6 weeks, 6 months, 12 months and 24 months post-operative

    The primary outcome measured for this study will be postoperative knee pain. This will be achieved using the Knee Injury and Osteoarthritis Outcome Score (KOOS) standardized questionnaire, which will be electronically delivered to participants at baseline and at 6-weeks, 6-months, 12-months and 24-months postoperatively. This questionnaire measures 42 items in a Likert scale for 5 different dimensions: pain, other symptoms, activities of daily living, function in sports and recreation and knee-related quality of life. The questionnaire is scored as a percentage from 0 to 100, with 0 representing extreme knee problems and 100 indicating no knee related symptoms, and therefore better outcomes.