NCT06311513 Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
| NCT ID | NCT06311513 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-01-22 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Miguel Otero, Ph.D.
PRINCIPAL INVESTIGATOR
Hospital for Special Surgery, New York
Frequently Asked Questions
Who can join the NCT06311513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06311513 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06311513 currently recruiting?
Yes, NCT06311513 is actively recruiting participants. Contact the research team at delahuertamezad@hss.edu for enrollment information.
Where is the NCT06311513 trial being conducted?
This trial is being conducted at Atlanta, United States, New York, United States.
Who is sponsoring the NCT06311513 clinical trial?
NCT06311513 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Miguel Otero, Ph.D. at Hospital for Special Surgery, New York. The trial plans to enroll 40 participants.