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Anterior Cruciate Ligament InjuriesPhase 4NCT06311513

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

A Phase 4 study testing Concentrated Bone Marrow Aspirate Injection and Revision Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Injuries and Post-Traumatic Osteoarthritis of Knee, run by Hospital for Special Surgery, New York at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Concentrated Bone Marrow Aspirate Injection and Revision Anterior Cruciate Ligament Reconstruction
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesUnited States
Study dates
22 Jan 2024to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel de la Huerta, MD contact

917-260-3159

delahuertamezad@hss.edu

United States2 sites, 2 recruiting

  • Emory Orthopaedics & Spine Center

    Atlanta, Georgia, 30097

    Recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Daniel de la Huerta, MD, 212-606-1000 ext. 2603159, delahuertamezad@hss.edu

    Miguel Otero, Ph.D.

    Recruiting

Other trials in United States

About this study

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)

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.

Read the detailed description

Anterior cruciate ligament reconstruction (ACLR) surgery is considered a relatively safe and effective procedure, however, up to 18% of grafts will fail and require revision surgery. Some studies have shown that these patients may be at increased risk of worse clinical outcomes, including fast progression toward post-traumatic osteoarthritis (PTOA). This is likely in part due to the inflammatory environment created within the joint. Concentrated bone marrow aspirate (cBMA) is a regenerative medicine therapy that contains soluble factors and connective tissue progenitor cells which may have immunomodulatory and pro-regenerative potential. The use of this therapy in conjunction with standard of care surgical treatment may help reduce the inflammatory microenvironment inside the joint, therefore modifying the conditions that might lead to developing long term complications such as PTOA.

The investigators hypothesize that cBMA treatment at the time of revision ACLR may improve clinical outcomes at 1 year after surgery and reduce the risk of developing PTOA-associated symptoms.

Participants will be randomized to either get a cBMA injection (investigational arm) at the time of surgery or a placebo incision (control arm). Biological specimens (blood, urine, synovial fluid), imaging data, functional tests and patient reported clinical outcomes will be measured at different time points during the study, for up to two years after the surgery. This will allow the investigators to evaluate the effect of cBMA in clinical outcomes. Biological specimens will be analyzed using molecular biology techniques to determine their composition, including the concentration of cells and other inflammatory markers.

Being tested
Concentrated Bone Marrow Aspirate Injection, Sham Incision, Revision Anterior Cruciate Ligament Reconstruction
Keywords
Regenerative Medicine, Orthobiologics, Concentrated Bone Marrow Aspirate, Revision ACLR
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concentrated Bone Marrow Aspirate InjectionBiological

    Also called cBMA, BMAC, Bone Marrow Aspirate Concentrate

    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.

  • Sham IncisionProcedure or surgery

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

  • Revision Anterior Cruciate Ligament ReconstructionProcedure or surgery

    Also called Revision ACLR

    This is the standard-of-care surgical procedure.

Study groups in NCT06311513
Study groupRoleWhat they receive
Investigational ArmExperimentalPatients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).
Receives: Biological: Concentrated Bone Marrow Aspirate Injection; Procedure: Revision Anterior Cruciate Ligament Reconstruction
Control ArmSham comparatorPatients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.
Receives: Procedure: Sham Incision; Procedure: Revision Anterior Cruciate Ligament Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in patient reported knee pain

    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.

    Measured: Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Secondary outcomes (4)

  1. Expression of local inflammatory biomarkers

    Synovial fluid collected before and 6 weeks after surgery will be analyzed using ELISA panels, looking for expression and concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII)

    Measured: Baseline and 6 weeks post-operative

  2. Concentration of circulating inflammatory biomarkers

    Biological samples (urine and blood) will be collected intraoperatively, and at 6-weeks and 12-months post-operatively. Samples will be processed and analyzed using ELISA panels, looking for the circulating concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII).

    Measured: Baseline, 6 weeks and 12 months post-operative

  3. Change from baseline in cartilage morphology

    Proton density weighted fast-spin-echo images will be acquired to assess cartilage morphology preoperatively and at 12 months post-operatively. Findings will be scored using the MRI Osteoarthritis Knee Score (MOAKS), which establishes criteria for assessing lesion grade (from 0 - best to 3 - worst) in fourteen distinct subregions.

    Measured: Baseline, 12 months post-operative

  4. Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization

    Combined T1ρ-T2 quantitative MRI image acquisition protocol will help determine the changes in relative proteoglycan content and collagen fibril organization within the knee articular cartilage.

    Measured: Baseline, 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start22 Jan 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single-blinded randomized controlled trial. Participants will be allocated to either: 1. Investigational arm (Revision ACLR + cBMA) 2. Control arm (Revision ACLR + Sham Incision)
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311513
Sponsor's protocol ID
2023-1017
Other IDs
1177535
Status last verified
Nov 2025
First submitted
8 Mar 2024
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Concentrated Bone Marrow Aspirate Injection and Revision Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Injuries and Post-Traumatic Osteoarthritis of Knee, run by Hospital for Special Surgery, New York at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel de la Huerta, MD (917-260-3159, delahuertamezad@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in patient reported knee pain (time frame: Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06311513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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