Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
Recruiting · NCT06311513 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital for Special Surgery, New York
View the official record on ClinicalTrials.gov →Interventions studied
Concentrated Bone Marrow Aspirate InjectionRevision Anterior Cruciate Ligament ReconstructionSham Incision
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 2 US states.
- Emory Orthopaedics & Spine Center - Atlanta, Georgia, United States
- Hospital for Special Surgery - New York, New York, United States