Abstract / Summary
Introduction Bone marrow aspirate (BMA) and bone marrow aspirate concentrate (BMAC) have emerged as autologous orthobiologic strategies aimed at modulating inflammation and promoting tissue repair in orthopedic conditions. However, evidence from randomized controlled trials (RCTs) remains heterogeneous, and their clinical role relative to established treatments is still debated. This systematic review aimed to evaluate the efficacy, structural effects, and safety of BMA and BMAC in adults with orthopedic conditions based exclusively on RCT evidence. Methods A systematic review was conducted according to PRISMA 2020 guidelines. PubMed, Embase, Scopus, and Web of Science were searched from December 2015 to December 2025. Eligible studies were RCTs comparing BMA or BMAC with placebo, conventional injective therapies, exercise therapy, or standard surgical procedures. Outcomes included pain, functional performance, imaging-based structural healing, treatment failure or revision, and safety. Risk of bias was assessed using the Cochrane RoB 2.0 tool, and results were synthesized narratively. Results Twenty-one RCTs involving knee osteoarthritis, ACL injury or reconstruction, rotator cuff tears, focal cartilage defects, osteonecrosis, discogenic low back pain, and glenohumeral osteoarthritis were included. Across trials, BMA/BMAC was generally associated with improvements in pain and function, although superiority over comparators was inconsistent and depended on the clinical condition and treatment strategy. Discussion Signals of greater benefit were observed in selected patients with early-stage knee osteoarthritis, focal cartilage pathology, nonsurgical ligament injuries, and rotator cuff disorders. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420251241519 , identifier CRD420251241519.