Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears

Purpose: To evaluate the clinical outcomes of patients who underwent biologically enhanced patch augmentation repair for the treatment of revision massive rotator cuff tears. Methods: Twenty-two patients who underwent arthroscopic and mini-open rotator cuff repair using a patch augmented with platelet-rich plasma and concentrated bone marrow aspirate (cBMA) for revision massive (≥2 tendons) rotator cuff tears from 2009 to 2014, with a minimum 1-year follow-up, were included in the study. In this procedure the medial side of the graft is secured to the rotator cuff tendon remaining medially. American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test, and postoperative Single Assessment Numerical Evaluation scores were evaluated. To determine the clinical relevance of ASES scores, the minimal clinically important difference, substantial clinical benefit (SCB), and the patient-acceptable symptomatic state (PASS) thresholds were used. Clinical success or failure was defined based on whether the patient reached the SCB threshold. In the laboratory, cellular counting along with the concentration of connective tissue progenitor cells were performed on patch samples from the day of surgery. Scaffolds were processed histologically at days 0, 7,14, and 21 of culture. Results: Patients had significant improvement in the Simple Shoulder Test (2.6 ± 3.0_pre vs 5.2 ± 4.2_post, P = .01), whereas improvement in pain scores was found to be nonsignificant (5.6 ± 2.5_pre vs 4.2 ± 3.4_post, P = .11) at final follow-up. Mean ASES improved by Δ14.6 ± 33.4 points; however, this did not reach statistical significance (40.2 ± 21.6_pre vs 53.9 ± 31.4_post, P = .10). With regards to ASES score, 45% of patients achieved the minimal clinically important difference, 41% the SCB, and 32% reached or exceeded the PASS criteria. At 21 days, there was a significantly greater cell count in scaffolds from patients who had clinical success than those who were failures (P = .02). Conclusions: Only 41% of patients undergoing biologically enhanced patch augmentation repair reached substantial clinical benefit, whereas 32% reached or exceeded the PASS criteria. Level of Evidence: Case Series: Level IV.