Prospective randomized controlled trial for patch augmentation in rotator cuff repair: 24-month outcomes
Prospective randomized controlled trial for patch augmentation in rotator cuff repair: 24-month outcomes
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DOI：
10.1016/j.jse.2019.05.043
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发表时间：
2019-10-01
影响因子：
3
通讯作者：
Zorzi, Claudio
中科院分区：
文献类型：
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作者：
Avanzi, Paolo;dei Giudici, Luca;Zorzi, Claudio
背景：旨在评估通过内侧单排并通过猪真皮补片增强的肩袖修复的解剖学完整性，并与未增强组进行比较。方法：我们进行了一项单中心、前瞻性、双盲、随机对照试验。样本量是预先确定的，患者被分为研究组和对照组，在术前以及 1、3、6、12 和 24 个月时进行评估。 EuroQol-视觉模拟量表； Constant-Murley 问卷；手臂、肩部和手部残疾评分；进行了简单肩部测试。根据X光照片计算肱骨-肩峰距离。肌腱厚度、撕裂延伸和肌腱信号强度均通过磁共振图像 (MRI) 进行测量，同时对足迹延伸进行评估，并将其分类为 4 个愈合等级（愈合、变薄、部分愈合、未愈合）之一。 结果：研究人群由 92 名患者组成，他们被随机分为 2 个同质组。 69 名患者完成了 24 个月的随访。研究组的治愈率为 97.6%，而标准修复组的治愈率为 59.5%。尽管肌腱密度相当，但研究组在修复肌腱厚度和足迹覆盖范围方面显示出更好的结果，P 值 < 0.05。研究小组提交的结果分数显示出更好的力量恢复和功能。在整个研究过程中，只有 2 名患者报告出现并发症，需要在翻修手术期间进行活检。结论：用猪真皮补片增强肩袖修复效果良好，具有更高的治愈率和接近正常的 MRI 结果。该技术安全、有效；此外，与标准的内侧单行修复相比，它具有可重复性，并且可以获得更好的结果。 (C) 2019 年肩肘外科杂志董事会。版权所有。
Background: To evaluate the anatomic integrity of rotator cuff repair performed by medialized single row and augmented by a porcine dermal patch, in comparison with a nonaugmented group.Methods: We conducted a single-center, prospective, double-blinded, randomized controlled trial. The sample size was predefined, and patients were divided into a study group and a control group, assessed preoperatively and at 1, 3, 6, 12, and 24 months. The EuroQol-visual analog scale; Constant-Murley questionnaire; Disabilities of the Arm, Shoulder and Hand Score; and Simple Shoulder Test were administered. The humeral-acromial distance was calculated on radiographs. Tendon thickness, tear extension, and tendon signal intensity were all measured on magnetic resonance images (MRIs) along with an evaluation of footprint extension and a classification into one of 4 healing grades-healed, thinned, partially healed, not healed.Results: The study population consisted of 92 patients who were equally randomized into 2 homogenous groups. Sixty-nine patients completed the 24-month follow-up. The study group showed a healing rate of 97.6% compared with 59.5% for the standard repair group. The study group showed better results in terms of repaired tendon thickness and footprint coverage, with a P value < .05, although the tendon density was comparable. The study group showed better strength recovery and functionality with the outcome scores submitted. During the entire study, only 2 patients reported complications, calling for a biopsy during revision surgery.Conclusions: Rotator cuff repairs augmented with a porcine dermal patch resulted in excellent clinical outcomes with a higher healing rate and close-to-normal MRI findings. The technique is safe and effective; in addition, it is reproducible and allows for better outcomes compared with those of standard medialized single-row repairs. (C) 2019 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.