Using concentrated bone marrow to improve outcomes in knee surgery
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)
Run by Hospital for Special Surgery, New York · NCT06311513 · Data updated 2026-11-12
This study is testing if using concentrated bone marrow during knee surgery can help people recover better and feel less pain after having their ACL surgery redone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | January 22, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06311513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 18 to 55 who have previously undergone ACL reconstruction and are scheduled for revision surgery due to graft failure.
✕Probably not a fit
Patients with a history of inflammatory arthritis, joint sepsis, or those who have had certain prior knee procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized clinical trial investigates the effectiveness of concentrated bone marrow aspirate (cBMA) in enhancing recovery and reducing post-traumatic osteoarthritis symptoms in patients undergoing revision anterior cruciate ligament reconstruction (ACLR). Participants will be randomly assigned to receive either a cBMA injection or a placebo during their surgery. The study will assess clinical outcomes, inflammation markers, and the cellular composition of cBMA over a two-year period. The goal is to determine if cBMA can improve pain and functional outcomes after surgery.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced risk of long-term complications for patients undergoing revision ACL surgery.
How similar studies have gone: Other studies have shown promise with similar regenerative approaches, but this specific application of cBMA in revision ACL surgery is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States Recruiting -
Hospital for Special Surgery
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Miguel Otero, Ph.D. — Hospital for Special Surgery, New York
- Study coordinator: Daniel de la Huerta, MD
- Email: delahuertamezad@hss.edu
- Phone: 917-260-3159
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Assessing ACL injury risk in healthy athletes
This study is trying to see how muscle strength and movement patterns in healthy athletes can help predict the risk of ACL injuries over a year.
-
Motor imagery–enhanced rehab after ACL reconstruction
This study tests whether mentally practicing movement can improve knee function and brain activity after ACL reconstruction, in comparison with standard rehab.
-
Functional Movement Training vs Functional Stability Training after ACL Surgery
This randomized trial tests whether a functional movement program or a stability-focused program helps 18-35 year old athletes recover after ACL surgery.
-
Intraoperative Energy Use During ACL Surgery
This study tests how much workload a surgeon experiences during ACL reconstruction procedures while wearing a Hexoskin shirt.
-
Differences in Outcomes After Allograft vs Autograft in Revision ACL Repair
This study looks at whether using donor tissue (allograft) versus the patient’s own tissue (autograft) in revision ACL surgery leads to different results.
-
Perturbation Training vs Functional Activities after ACL Reconstruction
This study tests whether perturbation training or task-oriented functional activities help people 18–45 with ACL reconstruction recover better than standard rehab.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.