Using concentrated bone marrow to improve outcomes in knee surgery
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)
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 |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06311513 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise with similar regenerative approaches, but this specific application of cBMA in revision ACL surgery is relatively novel.
Eligibility criteria
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 this trial is running
Atlanta, Georgia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.