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)
Hospital for Special Surgery, New York
Summary
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.
Description
Anterior cruciate ligament reconstruction (ACLR) surgery is considered a relatively safe and effective procedure, however, up to 18% of grafts will fail and require revision surgery. Some studies have shown that these patients may be at increased risk of worse clinical outcomes, including fast progression toward post-traumatic osteoarthritis (PTOA). This is likely in part due to the inflammatory environment created within the joint. Concentrated bone marrow aspirate (cBMA) is a regenerative medicine therapy that contains soluble factors and connective tissue progenitor cells which may have imm…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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 necr…
Interventions
- BiologicalConcentrated Bone Marrow Aspirate Injection
Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.
- ProcedureSham Incision
A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.
- ProcedureRevision Anterior Cruciate Ligament Reconstruction
This is the standard-of-care surgical procedure.
Locations (2)
- Emory Orthopaedics & Spine CenterAtlanta, Georgia
- Hospital for Special SurgeryNew York, New York