新型高强度 2 号圆形缝合线在肩袖修复中的不良事件或构造失败发生率低:IDEAL第2a阶段评估回顾性队列分析

Cooper Moody, Corey Scholes, Manaal Fatima, Kevin Eng, Graeme Brown, Richard S Page
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引用次数: 0

摘要

背景:尽管肩袖修复术(RCR)在技术和材料上有所改进,但临床和放射学上的失败仍很常见。缝合固定后,张力和足底压缩力从零开始下降。一种新型缝合线(Dynacord,Depuy Synthes)被设计为浸没在液体中时可缩短,以保持张力并提高修复结构的安全性。方法:对 PRULO(上肢手术患者报告结果)登记处进行了一项回顾性队列分析,对使用这种缝合线进行 RCR 术后 12 个月的随访情况进行了分析,分析内容包括各种原因导致的失败、常见并发症发生率、手臂、肩部和手部快速残疾指数 (QuickDASH) 以及西安大略肩袖指数 (WORC)。使用多重归因和线性模型分析患者特征和患者报告的结果指标(PROMs),并生成汇总统计数据,以评估随访 12 个月期间的变化。结果共纳入 236 个病例进行分析。并发症发生率和功能改善情况与类似缝合线的文献不相上下。在 12 个月的随访中,12% 的病例出现了全因治疗失败,QuickDASH 平均得分降低了 37 分,WORC 平均得分提高了 44 分,两者均超过了最小临床重要差异。我们观察到的并发症发生率如下:感染占 2.1%,僵硬/囊炎占 11%,再撕裂占 12%。结论新型缝合线具有良好的安全性和有效性,其结果与已发表的常用缝合线结果相当。这项通过 IDEAL 2a 外科创新框架进行的研究强调了这种缝合线的安全性,它能有效缓解常见的失败机制,并在 RCR 中取得令人满意的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Low incidence of adverse events or construct failure of a novel high-strength No.2 round suture in rotator cuff repair: An IDEAL Stage 2a assessment retrospective cohort analysis
Background: Despite technical and material improvements in rotator cuff repair (RCR) clinical and radiological failure remains common. Following suture fixation, tension and footprint compression decrease from time zero. A novel suture (Dynacord, Depuy Synthes) has been designed to shorten when submerged in liquid to maintain tension and increase repair construct security. Methods: A retrospective cohort analysis was performed on the PRULO (Patient Reported Outcomes in Upper Limb Surgery) registry for 12 months follow up after RCR using this suture regarding all cause failure, rates of common complications, Quick Disability of the Arm, Shoulder and Hand (QuickDASH), and Western Ontario Rotator Cuff Index (WORC). Summary statistics were generated for patient characteristics and patient-reported outcome measures (PROMs) analysed using multiple imputation and a linear model to assess changes over 12 months follow up. Results: A cohort of 236 cases was included for analysis. Complication rates and functional improvements were comparable to literature on similar sutures. At 12 months follow up, all-cause failure occurred in 12% of cases, and mean scores for QuickDASH decreased by 37 and WORC increased by 44, both of which surpass the minimum clinically important difference. Our observed rates of complications are as follows: Infection 2.1%, stiffness/capsulitis 11% and retear 12%. Conclusion: The novel suture demonstrated favourable safety and efficacy profiles, with outcomes comparable to those published for commonly used sutures. This study through an IDEAL 2a framework for surgical innovation highlights this suture as safe, effective in mitigating common failure mechanisms and having satisfactory outcomes in RCR.
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