Use of a Nanofiber Resorbable Scaffold During Rotator Cuff Repair: Surgical Technique and Results After Repair of Small- to Medium-Sized Tears.

Abstract

Background:The rate of retear after primary rotator cuff failure remains unacceptably high (up to 36% for small- to medium-sized tears). Augmentation of cuff repair with scaffold devices has been reported to improve healing after cuff repair.Purpose/Hypothesis:To describe the surgical technique of using an interpositional nanofiber scaffold during rotator cuff repair and report on a retrospective series of patients regarding functional outcomes and postoperative healing on magnetic resonance imaging (MRI). We hypothesized that augmentation of cuff repair with an interpositional scaffold would result in a high rate of tendon healing and excellent functional outcomes.Study Design:Case series; Level of evidence, 4.Methods:A total of 33 patients underwent arthroscopic rotator cuff repair augmented with a nanofiber, bioresorbable polymer patch secured as an inlay between the tendon and underlying bone. Patients were evaluated preoperatively and postoperatively with the Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES) shoulder score, and active range of motion (ROM) measurements. Postoperative MRI was used to evaluate repair status.Results:At a minimum follow-up of 6 months, the patients showed significant improvement on SST and ASES scores (P < .0001 for both). ROM in forward flexion, abduction, internal rotation, and external rotation significantly improved at 6 months postoperatively (P < .05 for all). MRI at an average of 11 months postoperatively showed healing in 91% of patients; one patient had a recurrent tear with transtendon failure, and another patient had retear at the insertional site. The patch was not visible on postoperative imaging, suggesting complete resorption in all patients. No adverse events were associated with the patch.Conclusion:Our results demonstrate the preliminary safety and efficacy of a novel, bioresorbable synthetic scaffold for rotator cuff repair. The use of the scaffold resulted in a 91% tendon healing rate and significant improvements in functional and patient-reported outcome measures. The results are promising for improving the current unacceptably high rate of rotator cuff repair failure.