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.
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)
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
Parallel
Concentrated Bone Marrow Aspirate Injection
Biological/VaccineIntraoperatively, 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.
Sham Incision
Procedure/SurgeryA 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.
Revision Anterior Cruciate Ligament Reconstruction
Procedure/SurgeryThis is the standard-of-care surgical procedure.
Change from baseline in patient reported knee pain
The primary outcome measured for this study will be postoperative knee pain. This will be achieved using the Knee Injury and Osteoarthritis Outcome Score (KOOS) standardized questionnaire, which will be electronically delivered to participants at baseline and at 6-weeks, 6-months, 12-months and 24-months postoperatively. This questionnaire measures 42 items in a Likert scale for 5 different dimensions: pain, other symptoms, activities of daily living, function in sports and recreation and knee-related quality of life. The questionnaire is scored as a percentage from 0 to 100, with 0 representing extreme knee problems and 100 indicating no knee related symptoms, and therefore better outcomes.
Expression of local inflammatory biomarkers
Synovial fluid collected before and 6 weeks after surgery will be analyzed using ELISA panels, looking for expression and concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII)
Concentration of circulating inflammatory biomarkers
Biological samples (urine and blood) will be collected intraoperatively, and at 6-weeks and 12-months post-operatively. Samples will be processed and analyzed using ELISA panels, looking for the circulating concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII).
Change from baseline in cartilage morphology
Proton density weighted fast-spin-echo images will be acquired to assess cartilage morphology preoperatively and at 12 months post-operatively. Findings will be scored using the MRI Osteoarthritis Knee Score (MOAKS), which establishes criteria for assessing lesion grade (from 0 - best to 3 - worst) in fourteen distinct subregions.
Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization
Combined T1ρ-T2 quantitative MRI image acquisition protocol will help determine the changes in relative proteoglycan content and collagen fibril organization within the knee articular cartilage.
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Hospital for Special Surgery, New York
Lead sponsor
Emory University
Collaborator
Arthritis Foundation
Collaborator
