Pilot Study of Concentrated Bone Marrow Aspirate to Improve Outcomes and Reduce Post-Traumatic Osteoarthritis After Revision Anterior Cruciate Ligament Reconstruction Surgery

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.

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction