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Abstract

Background: Evidence to justify the use of porcine small intestine submucosa (SIS) to augment large and massive rotator repairs is based on favorable results found in rabbit Achilles tendon and dog infraspinatus tendon repair studies. No published controlled study has evaluated the effectiveness of SIS augmentation of human rotator cuff repairs. The purpose of this study is to determine the effectiveness of SIS-Restore patch augmentation to repair chronic two tendon rotator cuff tears compared to repairs performed with the same techniques without SIS augmentation. Methods: Thirty shoulders with chronic two-tendon rotator cuff tears that were completely repairable by open surgery were randomized to either use SIS augmentation (Restore patch) or without the augmentation device. All patients completed a PENN shoulder score preoperatively and at their latest follow-up, which averaged 14 months (range 12-26.5). The size of the two-tendon tears was subcategorized into large or massive tears based on preoperative MRIs. Nine patients had large tears and twenty-one patients had massive tears. All patients underwent an MRI with intra-articular gadolinium one year after the repair to assess the status of the rotator cuff. Results: The percentage of patients with a healed rotator cuff in the SIS group was twenty-seven percent, and in the control group was sixty percent, which was not significant (p=0.11). After adjusting for the effect of tear size on the rate of healing, repairs without SIS-Restore augmentation were seven percent more likely to heal than repairs augmented with SIS-Restore (p=0.07). The postoperative PENN total score for the SIS-Restore group was ninety-one and for the control group was eighty-three, which was not significant (p=0.07). Healing of the cuff defect demonstrated a strong correlation with patient clinical scores regardless if a Restore patch was used. The postoperative PENN total scores for the healed repairs was ninety-six, and for the failed repairs was eighty-one, which was significant (p=0.02). The preoperative to postoperative percentage change in the PENN satisfaction score for the healed repairs was 400%, and for the failed repairs was 50%, which was significant (p=0.05). Conclusions: In large and massive chronic cuff tears, SIS-Restore did not increase improve the rate of tendon healing or the clinical outcome scores. There is a trend for the SIS group to have less favorable clinical outcomes in these types of tears. Based on these data, we do not recommend using SIS-Restore for the augmentation of massive chronic rotator cuff repairs using the surgical and post-operative procedures described in this study. If noted, the author indicates something of value received. The codes are identified as follows: a, research or institutional support; b, miscellaneous funding; c, royalties; d, stock options; e, consultant or employee. *The Food and Drug Administration has not cleared the drug and/or medical device for the use described in this presentation (ie, the drug or medical device is being discussed for an “off-label” use). If noted, the author indicates something of value received. The codes are identified as follows: a, research or institutional support; b, miscellaneous funding; c, royalties; d, stock options; e, consultant or employee. *The Food and Drug Administration has not cleared the drug and/or medical device for the use described in this presentation (ie, the drug or medical device is being discussed for an “off-label” use). If noted, the author indicates something of value received. The codes are identified as follows: a, research or institutional support; b, miscellaneous funding; c, royalties; d, stock options; e, consultant or employee. *The Food and Drug Administration has not cleared the drug and/or medical device for the use described in this presentation (ie, the drug or medical device is being discussed for an “off-label” use).