Summary: biologic augmentation with a bioinductive Collagen patch improves clinical and functional outcomes in patients undergoing revision rotator cuff tear repair

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 and full thickness RCT and even massive tears. However, the effect of the patch on the repair of rotator cuff retears remains unclear.

Aim

To analyze the effect of the collagen patch on functional outcomes and pain levels during the first 12-months postoperative in patients with rotator cuff retear and a previous arthroscopic rotator cuff repair and to evaluate the effect of the collagen patch on tendon integrity.

Methods

Observational, prospective multicenter study of patients who diagnosed with rotator cuff retear after a previous arthroscopic rotator cuff repair scheduled for a new arthroscopic rotator cuff repair with an additional bioinductive collagen implant (REGENETEN, Smith&Nephew, Andover, MA). Patients diagnosed using MRI of rotator cuff full-thickness retear after surgery and a minimum one-year follow-up were included in this study. Presence of a subscapularis tear or a posterosuperior rotator cuff considered irreparable or partially reparable at the time of surgery; severe muscular atrophy (Goutallier grade <3) and previous surgery or injuries involving the shoulder different from the prior rotator cuff repair surgery were considered exclusion criteria. Pain levels measured with VAS score, functional outcomes, evaluated with the Constant Murley and ASES scores, and single Assessment Numeric Evaluation score (SANE) were recorded preoperatively and postoperatively. Integrity of the repaired tendon was evaluated at 12-months follow up in an MRI study using Sugaya et al. classification. Repairs graded as IV and V according to Sugaya classification were defined as retear.

Results

Twenty-four patients, 62.5% male, median age at surgery 57.6 years (range 38-67), with a mean follow-up of 17.5 months (range 12-24) were included. No intraoperative or immediate postoperative complications occurred. Range of movement did not significantly differ from preoperative to postoperative. VAS score significantly decreased from preoperative, noted at 8 (range 4-10), to postoperative, noted at 5 (range 0-8) (p=0.001). Regarding functional outcomes, Constant and ASES scores significantly improved from 41.5 and 21.6 to 61.5 and 58.3 respectively at 12 months follow-up (p=0.004; p=0.0001). The mean SANE score after revision surgery was 60 points (range 10-100). MR imaging revealed an overall retear rate of 29.2% (7/24). Of these, in 4 cases, the identified retear size was smaller than the initial tear. Multiregression analysis showed no correlation between retear and demographic data, preoperative tear pattern including size or atrophy, and surgical data (tear pattern or repair technique). Only one patient underwent revision surgery.

Conclusion

Biologic augmentation with a bioinductive collagen patch improves clinical and functional outcomes in patients undergoing revision rotator cuff tear repair. Future comparative studies are needed to define the role of this device in revision rotator cuff tear surgery.

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Biological Augmentation In Revision Surgery: A Pilot Study Of The Effect Of A Bioinductive Collagen Patch In Patients With Rotator Cuff Retear And A Previous Arthroscopic Rotator Cuff Repair.

Biological Augmentation In Revision Surgery: A Pilot Study Of The Effect Of A Bioinductive Collagen Patch In Patients With Rotator Cuff Retear And A Previous Arthroscopic Rotator Cuff Repair.

Background

Aim

Methods

Results

Conclusion

Shoulder Rotator Cuff ePosters

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Biological Augmentation In Revision Surgery: A Pilot Study Of The Effect Of A Bioinductive Collagen Patch In Patients With Rotator Cuff Retear And A Previous Arthroscopic Rotator Cuff Repair.

Biological Augmentation In Revision Surgery: A Pilot Study Of The Effect Of A Bioinductive Collagen Patch In Patients With Rotator Cuff Retear And A Previous Arthroscopic Rotator Cuff Repair.

Background

Aim

Methods

Results

Conclusion