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: 5.28). 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.

    • "Regarding irreparable tears, Rockwood et al. defined them as tears that cannot be repaired primarily to the site of their insertion into the tuberosities, despite conventional techniques of mobilization and soft tissue release.[15] Restoration of this injury is very important due to the extremely uncomfortable symptoms.[16] The prevalence of r-c tears has also estimated to represent a 30% in the general population.[17] "
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    ABSTRACT: Purpose:Despite advances in surgical treatment options, large rotator cuff (r-c) tears still represent a challenge for orthopedic surgeons. The purpose of this study was to evaluate the temporary and spatial histological incorporation of fascia lata allografts, used for bridging artificially created defects of the r-c.Materials and Methods:Seventy-two rabbits were divided into two groups and a supraspinatus tendinous defect was created. Half of the rabbit population underwent repair only, while in the other half, the defect was bridged utilizing fascia lata allograft. The animals were euthanized at 2, 4, and 6 weeks postoperative. Half of the specimens were evaluated histologically and the other half underwent mechanical testing.Results:There was an increased remodeling activity, fibroblastic in growth and strong presence of collagen fibers observed at 6 weeks on both groups. A gradually increasing mechanical strength was noticed by week 6 and increased toughness was also found at the same time period. There was no significant difference observed between the two groups regarding their histological and mechanical properties.Conclusions:In the difficult scenario of a large irreparable tear where the simple suture of the remaining r-c is impossible, allograft bridging, could be used with satisfactory results.Clinical Relevance:Treatment Study, Level 1.
    International Journal of Shoulder Surgery 04/2014; 8(2):39-46. DOI:10.4103/0973-6042.137526 · 0.65 Impact Factor
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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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    ABSTRACT: As dense connective tissues connecting bone to muscle and bone to bone, respectively, tendon and ligament (T/L) arise from the somitic mesoderm, originating in a recently discovered somitic compartment, the syndetome. Inductive signals from the adjacent sclerotome and myotome upregulate expression of Scleraxis, a key transcription factor for tenogenic and ligamentogenic differentiation. Understanding T/L development is critical to establishing a knowledge base for improving the healing and repair of T/L injuries, a high-burden disease due to the intrinsically poor natural healing response. Current treatment of the three most common tendon injuries-tearing of the rotator cuff of the shoulder, flexor tendon of the hand, and Achilles tendon-include mostly surgical repair and/or conservative approaches, including biophysical modalities such as rehabilitation and cryotherapy. Unfortunately, the fibrovascular scar formed during healing possesses inferior mechanical and biochemical properties, resulting in compromised tissue functionality. Regenerative approaches have sought to augment the injured tissue with cells, scaffolds, bioactive agents, and mechanical stimulation to improve the natural healing response. The key challenges in restoring full T/L function following injury include optimal combination of these biological agents as well as their delivery to the injury site. A greater understanding of the molecular mechanisms involved in T/L development and natural healing, coupled with the capability of producing complex biomaterials to deliver multiple biofactors with high spatiotemporal resolution and specificity, should lead to regenerative procedures that more closely recapitulate T/L morphogenesis, thereby offering future patients the prospect of T/L regeneration, as opposed to simple tissue repair. Text. Birth Defects Research (Part C) 99:203-222, 2013. © 2013 Wiley Periodicals, Inc.
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    • "We also had seven tears that qualified as “massive”, according to Gerber et al.[1] Definition of complete rupture of two or more tendons. Gerber's and other studies,[720283435363738] looked at “massive” chronic tears and discovered re-tear rates from 34% to 94% and poorer outcomes in those with unhealed repairs. We found in our evaluation of those with “massive” tears, five out of seven (71%) had no re-tears at a minimum of 1 year of ultrasound evaluation. "
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    ABSTRACT: This study evaluated retraction in the setting of acute rotator cuff tears and determined its effects on patient outcomes and tendon repair integrity. A total of 22 patients had surgery within 6 weeks or less from the time of injury. Fifteen of these patients were prospectively followed at a minimum of 2 years; average 40.5 months (range 24-69). Pre-operative objective and subjective outcomes were compared. Tendon repair integrity was assessed with ultrasound at a minimum of 1 year from surgery. The population was stratified into Group 1 (8 patients) with minimal intra-operative medial tendon retraction to the mid-line level of the humeral head and Group 2 (7 patients) with a large medial tendon retraction to the glenohumeral joint or greater. The average time to surgery from the onset of symptoms was 27 days (range, 6-42). Post-operative motion increased significantly for external rotation and forward elevation, 77% of patients were pain free, 80% were completely satisfied, and 100% would have the surgery again. Group 1 (small retraction) versus Group 2 (large retraction) showed that post-operative pain levels, satisfaction, range of motion, strength, subjective shoulder value (95.4% vs. 92.3%), Constant Score (80.8 vs. 78.1), and American Society of Shoulder and Elbow Surgeons (96.2 vs. 93.5) scores were not statistically different. Ultrasound showed a tendon repair integrity rate of 87%. 2 patients who did have a re-tear were in Group 2, yet had comparative outcomes. In acute rotator cuff tears, equal patient satisfaction, pain scores, range of motion, strength, and outcome measures should be expected with surgical repair despite the level of retraction. Therapeutic level IV.
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