Arthroscopic Rotator Cuff Repair with a Fibrin Scaffold Containing Growth Factors and Autologous Progenitor Cells Derived From Humeral cBMA Improves Clinical Outcomes in High Risk Patients

Purpose To report the clinical outcomes after biologically augmented rotator cuff repair (RCR) with a fibrin scaffold derived from autologous whole blood and supplemented with concentrated bone marrow aspirate (cBMA) harvested at the proximal humerus. Methods Patients who underwent arthroscopic RCR with biologic augmentation using a fibrin clot scaffold (“Mega‐ Clot”) containing progenitor cells and growth factors from proximal humerus BMA and autologous whole blood between April 2015 and January 2018 were prospectively followed. Only high‐risk patients in primary and revision cases that possessed relevant comorbidities or physically demanding occupation were included. Minimum follow‐up for inclusion was 1 year. The visual analog score for pain (VAS), American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test (SST), Single Assessment Numerical Evaluation (SANE), and Constant‐Murley scores were collected preoperatively and at final follow‐up. In vitro analyses of the cBMA and fibrin clot using nucleated cell count, colony forming units, and live/dead assays were used to quantify the substrates. Results Thirteen patients (56.9 ± 7.7 years) were included. The mean follow‐up was 26.9 ± 17.7 months ( n = 13). There were significant improvements in all outcome scores from the preoperative to the postoperative state: VAS (5.6 ± 2.5 to 3.1 ± 3.2; P < .001), ASES (42.0 ± 17.1 to 65.5 ± 30.6; P < .001), SST (3.2 ± 2.8 to 6.5 ± 4.7; P = .002), SANE (11.5 ± 15.6 to 50.3 ± 36.5; P < .001), and Constant‐Murley (38.9 ± 17.5 to 58.1 ± 26.3; P < .001). Six patients (46%) had retears on postoperative MRI, despite all having improvements in pain and function except one. All failures were chronic rotator cuff tears, and all were revision cases except one (1.6 ± 0.5 previous RCRs). The representative sample of harvested cBMA showed an average of 28.5 ± 9.1 × 10 6 nucleated cells per mL. Conclusions Arthroscopic rotator cuff repairs that are biologically augmented with a fibrin scaffold containing growth factors and autologous progenitor cells derived from autologous whole blood and humeral cBMA can improve clinical outcomes in primary, as well as revision cases in high‐risk patients. However, the incidence of retears remains a concern in this population, demanding further improvements in biologic augmentation. Level of Evidence IV, therapeutic case series.