Article

Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears - A randomized, controlled trial

Department of Orthopaedic Surgery A-41, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
The Journal of Bone and Joint Surgery (Impact Factor: 4.31). 07/2006; 88(6):1238-44. DOI: 10.2106/JBJS.E.00524
Source: PubMed

ABSTRACT Evidence to justify the use of porcine small intestine submucosa to augment repairs of large and massive rotator cuff tears is based on favorable results found in studies of Achilles tendon and infraspinatus tendon repairs in canines. The purpose of this study was to determine the effectiveness of a small intestine submucosal patch to augment the repair of chronic two-tendon rotator cuff tears in humans.
Thirty shoulders with a chronic two-tendon rotator cuff tear that was completely repairable with open surgery were randomized to be treated with either augmentation with porcine small intestine mucosa or no augmentation. All patients completed a PENN shoulder-score questionnaire preoperatively and at the time of the latest follow-up (at an average of fourteen months). Magnetic resonance imaging showed that nine shoulders had a large tear and twenty-one had a massive tear. All patients underwent a magnetic resonance imaging scan with intra-articular gadolinium one year after the repair to assess the status of the rotator cuff.
The rotator cuff healed in four of the fifteen shoulders in the augmentation group compared with nine of the fifteen in the control group (p = 0.11). The median postoperative PENN total score was 83 points in the augmentation group compared with 91 points in the control group (p = 0.07). Healing of the defects in both groups demonstrated a strong correlation with the patients' clinical scores. The median postoperative PENN total score was 96 points in the group with a healed repair and 81 points in the group with a failed repair (p = 0.007). The percentage change between the preoperative and postoperative patient satisfaction scores was 400% in the group with a healed repair, and 50% in the group with a failed repair (p = 0.04).
Augmentation of the surgical repair of large and massive chronic rotator cuff tears with porcine small intestine submucosa did not improve the rate of tendon-healing or the clinical outcome scores. On the basis of these data, we do not recommend using porcine small intestine submucosa to augment repairs of massive chronic rotator cuff tears done with the surgical and postoperative procedures described in this study.

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    • "Given the high re-tear rates experienced with current surgical approaches, scaffolds designed to provide mechanical augmentation or enhance biological healing have been investigated in both animal and human studies. Only two prospective randomized, controlled trials have been performed using commercially available devices consisting of decellularized extracellular matrices (Barber et al., 2012; Derwin et al., 2006; Iannotti et al., 2006). While one of these studies found improved subjective clinical scores in patients with scaffold-augmented repairs (Barber et al., 2012), animal models with the same augmented repair did not recapitulate the native bone-tendon interface (Dejardin et al., 2001). "
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    • "Biologic scaffolds composed of extracellular matrix (ECM) can facilitate the constructive remodeling of numerous tissues including esophagus [1] [2], lower urinary tract [3] [4], muscle and tendon [5] [6], and myocardium [7] [8], among others. Although the mechanisms by which ECM scaffolds promote a constructive and functional remodeling response are only partially understood, recruitment of endogenous multipotent progenitor cells [9] [10], modulation of the innate immune response [11] [12], scaffold degradation with the generation of bioactive molecular cues [13e15], and innervation [16] have all been shown to be important events in this process. "
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    • "Promising results with the majority of these biomaterials have been obtained in animal studies [20] [21] [22] [23] [24]. Also results of clinical applications have been reported with biological materials such as allografts, Swine Intestinal Submucosa (SIS) and porcine dermal collagen implants, but, to the present authors' knowledge, some clinical studies have failed to demonstrate improved healing or good functional outcomes with the use of these ECM membranes [6] [25] [26] [27] [28] [29] [30]. To the present author's knowledge, literature data suggest that decellularized membranes from human dermis did not cause complications after augmentation surgery in patients with massive rotator cuff tears [18] [31] [32]. "
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