Actively Recruiting
Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate (cBMA) as a Treatment to Modify Post-Traumatic Osteoarthritis Following Revision Anterior Cruciate Ligament Reconstruction
Led by Hospital for Special Surgery, New York · Updated on 2025-11-20
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of concentrated bone marrow aspirate (cBMA) to improve symptoms of post-traumatic osteoarthritis (PTOA) in patients undergoing revision anterior cruciate ligament reconstruction (ACLR) surgery. This pilot randomized clinical trial aims to determine if adding cBMA to revision ACLR can improve clinical outcomes like pain and reduce inflammation that may contribute to PTOA. The study also investigates the cellular and molecular components of cBMA to understand how it might affect these outcomes. Participants will be randomly assigned to receive either an intraoperative injection of cBMA harvested from their own iliac crest or a sham incision instead of bone marrow harvesting, alongside their revision ACLR surgery. The cBMA is prepared through centrifugation and injected into the operative knee during surgery. All participants will undergo standard revision ACLR surgery and follow a standardized physical therapy program. Throughout the study, participants will be followed for up to two years with assessments at baseline, 6 weeks, 6 months, 12 months, and 24 months after surgery. Evaluations include patient-reported knee pain, imaging studies to assess cartilage changes, measurement of inflammatory biomarkers in blood, urine, and synovial fluid, functional tests, and clinical outcome questionnaires. These measures will help determine the effect of cBMA on pain, inflammation, and joint health over time.
CONDITIONS
Brief Title
Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants
- Age between 18 and 55 years
- Previous unilateral ACL reconstruction within the last 5 years with failure of the primary surgery
- Scheduled for revision ACL reconstruction surgery with any graft type
- Able to complete all study procedures and participate in standardized physical therapy
You will not qualify if you...
- History of inflammatory arthritis or joint infection
- Prior or current total or sub-total meniscectomy
- Prior or present avascular necrosis of the knee being studied
- Corticosteroid injection in the knee within the past 3 months
- Hyaluronic acid or platelet-rich plasma injection within the past 6 months
- Use of duloxetine, doxycycline, indomethacin, glucosamine, or chondroitin ongoing or within the past 2 months
- Any clinical or laboratory abnormality greater than grade 3 CTCAE that may compromise safety
- Planned knee arthroplasty surgery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo revision ACL reconstruction surgery. During the surgery, they will either receive a concentrated bone marrow aspirate injection or a sham incision as part of the study.
1 surgical visit (in-person)
Duration - Up to 24 months post-surgery
Participants are monitored and assessed through clinical outcomes, biological specimen collection, imaging, and functional tests after surgery to evaluate treatment effects.
Visits at 6 weeks, 6 months, 12 months, and 24 months post-operative
Trial Site Locations
Total: 2 locations
1
Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States, 30097
Actively Recruiting
2
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
D
Daniel de la Huerta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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