Biological augmentation in revision surgery: effect of a bioinductive collagen patch in patients with rotator cuff retear and a previous arthroscopic rotator cuff repair.

Abstract

Biologic augmentation with a bioinductive collagen patch has been proposed as an alternative to improve the healing rate of rotator cuff tears (RCT). Several studies have reported promising results when treating partial, full-thickness, and even massive tears. However, the effect of the patch on the repair of rotator cuff retears remains unclear. To analyze the effect of the collagen patch on tendon integrity in patients with rotator cuff retear and a previous rotator cuff repair, and to evaluate the effects of the bioinductive implant on functional outcomes and pain levels at the first 24-months postoperatively. Observational, prospective multicenter study of patients diagnosed with rotator cuff retear after prior arthroscopic rotator cuff repair, scheduled for a new arthroscopic repair with the addition of a bioinductive collagen implant (REGENETEN, Smith&Nephew, Andover, MA, USA). The primary outcome was integrity of the repaired tendon evaluated at 12-months follow-up in an MRI study using Sugaya classification. Repairs graded as Sugaya IV and V were defined as retear. Secondary outcome measures included pain levels measured with visual analog score (VAS) and functional outcomes, evaluated with the Constant Murley (CS), American Shoulder and Elbow Surgeons (ASES), and single Assessment Numeric Evaluation scores at 24-months follow-up. Twenty-one patients, 57.1% male, median age at surgery 59 years (range 46-67), with a median follow-up of 25.9 months (range 24-34) were included. No intraoperative or immediate postoperative complications occurred. MR imaging revealed an overall retear rate of 28.6% (6/21). Of these, in 3 cases, the identified retear size was smaller than the initial tear. Only one patient underwent revision surgery. VAS score significantly decreased from preoperative, median 8 (range 4-10), to postoperative, median 5 (range 0-8) (p=0.001). Regarding functional outcomes, Constant and ASES scores significantly improved from 44 and 20 respectively to 63 and 59.2 at 24 months follow-up (p=0.004; p=0.0001). The mean subjective shoulder value score after revision surgery was 60 points (range 10-100). Biologic augmentation with a bioinductive collagen patch provides clinical and functional improvement in patients undergoing revision rotator cuff tear repair, with over 70% of the revision repairs remaining intact at 1-year follow-up.