Short-term radiographic and clinical outcomes of arthroscopic rotator cuff repair with and without augmentation with an interpositional nanofiber scaffold

The rate of retear after primary rotator cuff failure remains unacceptably high (up to 36% for small- to medium-sized tears). Augmentation of the repair with an interpositional scaffold has been reported to improve healing. To compare the short-term radiographic and clinical outcomes of arthroscopic rotator cuff repair with and without augmentation with an interpositional nanofiber scaffold. We prospectively enrolled patients with full thickness rotator cuff tears into a multicenter study with institutional review board approval. All patients had a minimum of one year clinical and radiographic follow-up. A single fellowship trained shoulder surgeon performed all procedures. Patients were blinded and randomized at the time of surgery into either a treatment group consisting of double row rotator cuff repair augmented with an interpositional nanofiber scaffold or a control group in which a standard double-row repair without augmentation was performed. Range of motion, muscle dynamometer strength testing (Lafayette Instruments), and clinical outcomes according to visual analog scale pain, American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) scores were assessed preoperatively and at routine follow-up intervals. Magnetic resonance imaging (MRI) was obtained at a minimum of 4 months (range 4.5-14) on all patients and assessed according to the Sugaya classification with failure noted as grade 4 or higher. Patients without initial failure were then assessed at a minimum of one year (range 12-24 months) by ultrasound examination or MRI to assess for late failure of the repair and clinical outcomes. Thirty patients with a mean age of 64.6 years were statistically analyzed. Fourteen patients were treated with the nanofiber scaffold and 16 patients were non-augmented and made up the control. At an average of 6.8 months, all patients underwent MRI and early failure occurred in 7.1% of the nanofiber scaffold patients compared to 18.8% in the control group (p=.602). At an average time of 17 months postoperatively, all remaining patients with intact repairs underwent MRI (2) or ultrasound (28) and 9 more patients demonstrated Sugaya tear progression with five progressing to failure. All late failures and Sugaya tear progressions occurred in the control group. Cumulative treatment failure occurred significantly less often in patients who received the nanofiber scaffold (7.1%) compared to those who did not receive the bioresorbable scaffold (50%) (p=.017). The present prospective study demonstrates a statistically significant difference in rotator cuff healing with use of an interpositional nanofiber scaffold. While future studies and larger series are warranted, the current data is promising in further advancing the outcomes of rotator cuff repairs.