Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears - A randomized, controlled trial
Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears - A randomized, controlled trial
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DOI：
10.2106/jbjs.e.00524
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发表时间：
2006-06-01
影响因子：
5.3
通讯作者：
Brems, JJ
中科院分区：
文献类型：
--
作者：
Iannotti, JP;Codsi, MJ;Brems, JJ
背景：证明使用猪小肠粘膜下层来增强大面积肩袖撕裂修复的证据是基于犬科动物跟腱和冈下肌腱修复研究中发现的有利结果。本研究的目的是确定小肠粘膜下补片增强人体慢性二腱肩袖撕裂修复的有效性。方法：30 名患有慢性二腱肩袖撕裂且可通过开放手术完全修复的肩膀被随机分配接受猪小肠粘膜增强治疗或不增强治疗。所有患者在术前和最后一次随访时（平均十四个月）完成了 PENN 肩部评分问卷。磁共振成像显示，九个肩膀有很大的撕裂，二十一个肩膀有很大的撕裂。所有患者在修复一年后均接受了关节内钆磁共振成像扫描，以评估肩袖的状态。 结果：增强组 15 个肩部中有 4 个肩部的肩袖愈合，而对照组 15 个肩部中有 9 个肩部愈合（p = 0.11）。增强组术后 PENN 总分中位数为 83 分，而对照组为 91 分 (p = 0.07)。两组缺损的愈合均与患者的临床评分密切相关。修复愈合组的术后 PENN 总分中位数为 96 分，修复失败组为 81 分 (p. = 0.007)。修复愈合组术前和术后患者满意度评分之间的百分比变化为 400%，修复失败组为 50%（p = 0.04）。结论：用猪小肠粘膜下层加强大面积慢性肩袖撕裂的手术修复并没有提高肌腱愈合率或临床结果评分。根据这些数据，我们不建议使用猪小肠粘膜下层来增强通过本研究中描述的手术和术后程序进行的大规模慢性肩袖撕裂的修复。
Background: 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.Methods: 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.Results: 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).Conclusions: 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.