Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Key facts
- Who runs it
- Hospital for Special Surgery, New York
- Where
- Atlanta and New York, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 40 people, planned
- Started
- 22 Jan 2024
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Concentrated Bone Marrow Aspirate Injection
- Sham Incision
- Revision Anterior Cruciate Ligament Reconstruction
- Record updated
- 20 November 2025
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- 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
- History of inflammatory arthritis or joint sepsis
- Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months
- Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety
- Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months)
- Planned arthroplasty in the index knee
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Where in United States
- Emory Orthopaedics & Spine CenterAtlanta, United StatesContact: Daniel de la Huerta, MDTaking people
- Hospital for Special SurgeryNew York, United StatesContact: Daniel de la Huerta, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Investigational ArmTreatment being tested
Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).
Treatment: Concentrated Bone Marrow Aspirate Injection and Revision Anterior Cruciate Ligament Reconstruction
- Control ArmSham treatment, for comparison
Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.
Treatment: Sham Incision and Revision Anterior Cruciate Ligament Reconstruction
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Fit questions
- Built from NCT06311513, who can take part
- Record updated
- 20 November 2025