Design and rationale of a prospective randomized trial of biologic augmentation with bone marrow aspirate concentrate (BMAC) in arthroscopic reconstruction of rotator cuff tear

Introduction. Rotator cuff tears are a common shoulder pathology with an increasing incidence, reaching up to 20% in the population, while currently no downward trend is observed. Although we have witnessed remarkable advances in the diagnosis and surgical treatment based on solid science and extensive clinical practice, considerable controversy remains over the optimal reproducible clinical outcomes.Purpose is to compare the effects of the arthroscopic treatment for medium to large rotator cuff tears with and without bone marrow aspirate concentrate (BMAC) augmentation.Materials and methods: The prospective randomized trial will enroll eligible patients (n = 80). Patients will be randomly assigned (1:1) to the experimental group (arthroscopic rotator cuff suture repair with BMAC application) and the control group (arthroscopic rotator cuff suture repair without BMAC application). Outcomes will be assessed at 3, 6, 12 months after surgery by magnetic resonance imaging and with respect to functional scores using the scoring systems ASES, DASH, UCLA and SST.Results: The hypothesis of the study is that the arthroscopic repair of rotator cuff tears augmented by BMAC will improve tissue integrity, while the rates of reducing pain and improving function will be comparable.Discussion: Remarkable advances in rotator cuff repair involve the combination of cell-based and biological therapies and advanced surgical approaches. The planned prospective trial will determine the role of biological augmentation in outcomes of arthroscopic rotator tears repair.