JSES - 2026-04-01 - Journal Article; Multicenter Study; Observational Study
Biological augmentation in revision surgery: effect of a bioinductive collagen patch (REGENETEN) in patients with rotator cuff retear and a previous arthroscopic rotator cuff repair.
Delgado C, Rodríguez G, Ortega C, López V, Ardévol J, Calvo E
Topics
Key Takeaway
Revision rotator cuff repair augmented with a bioinductive collagen patch (REGENETEN) achieved a 71.4% structural integrity rate at 12 months MRI (Sugaya I–III) with significant functional improvement (Constant score 44→63, ASES 20→59.2) in 21 patients.
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Summary
This prospective multicenter observational study evaluated bioinductive collagen patch augmentation (REGENETEN) added to revision arthroscopic rotator cuff repair in 21 patients with confirmed retear after prior arthroscopic repair. Primary outcome was tendon integrity by Sugaya classification at 12 months MRI; secondary outcomes were VAS, Constant-Murley, ASES, and SANE scores at 24 months. Retear rate was 28.6% (6/21), with 3 of those retears smaller than the index tear; VAS improved from 8 to 5 (P=.001), Constant from 44 to 63 (P=.004), and ASES from 20 to 59.2 (P=.0001).
Key Limitation
The absence of a concurrent control group of revision repairs without patch augmentation makes it impossible to determine whether the 71.4% integrity rate and functional improvements are attributable to the REGENETEN implant or to the revision repair alone.
Original Abstract
BACKGROUND
Biologic augmentation with a bioinductive collagen patch has been proposed as an alternative to improve the healing rate of rotator cuff tears. 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.
METHODS
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 a magnetic resonance imaging 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 scale and functional outcomes, evaluated with the Constant Murley, American Shoulder and Elbow Surgeons, and Single Assessment Numeric Evaluation scores at 24 months follow-up.
RESULTS
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. Magnetic resonance 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. Visual analog scale score significantly decreased from preoperative, median 8 (range 4-10), to postoperative, median 5 (range 0-8) (P = .001). Regarding functional outcomes, Constant and American Shoulder and Elbow Surgeons scores significantly improved from 44 and 20, respectively to 63 and 59.2 at 24 months follow-up (P = .004; P = .0001). The mean subjective shoulder value score after revision surgery was 60 points (range 10-100).
CONCLUSION
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.