Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called concentrated bone marrow aspirate (cBMA) can help improve symptoms of post-traumatic osteoarthritis in patients who are having surgery to fix a previous knee injury. Specifically, the study is looking at how cBMA, when used during revision surgery for an anterior cruciate ligament (ACL) injury, might reduce pain and improve overall knee function. Researchers will also examine changes in inflammation markers in the body and the specific components of cBMA that may contribute to its effects.

To be eligible for this trial, participants must be between 18 and 55 years old, have previously undergone ACL reconstruction surgery in the last five years, and be scheduled for another surgery due to a failure of the first procedure. Participants will need to commit to following a physical therapy program as part of the study. It's important to note that individuals with certain medical conditions, previous knee surgeries, or recent treatments that could affect their participation are not eligible. Those who join the trial can expect to receive the cBMA treatment during their revision surgery and will be monitored for its effectiveness in improving their knee health.

Gender

ALL

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