瓣环关闭装置可降低症状性再疝发生率:元分析结果

Sidhant S. Dalal, Kasra Araghi, Eric Mai, Omri Maayan, Karim A. Shafi, Pratyush Shahi, Daniel Shinn, Junho Song, C. Gang, S. Iyer, Sheeraz A Qureshi
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引用次数: 0

摘要

背景:现有环空闭合器(ACD)研究的长期随访数据范围有限。缺乏报告和分析ACD使用后近期结果数据的研究。目的:我们试图总结Barricaid (Intrinsic Therapeutics) ACD术后预后的长期随访数据。方法:根据系统评价和荟萃分析指南的首选报告项目,检索PubMed、Cochrane和OVID数据库,以确定2015年以后的研究,这些研究包括在临床背景下直接评估ACD,至少随访2年,包括再疝和并发症发生率,而不包括病例报告、综述和荟萃分析。结果测量包括患者人口统计学、研究特征、手术技术、缺陷测量技术、围手术期统计、放射学评估、并发症、患者报告的结果测量(PROMs)和术后结果。结果:共纳入5项研究,包括2项随机对照试验(rct)、2项回顾性研究和1项前瞻性队列研究。ACD人群的症状性再疝率从3%到18.8%不等。两项研究发现,对照组明显高于ACD组(ACD组18.8% vs非ACD组31.6%,ACD组3.33% vs非ACD组20.0%)。两组再手术率无明显差异。在报告PROMs数据的4项研究中,所有研究都观察到每个队列的相对改善,尽管合并分析未发现ACD组和非ACD组在2年随访时的Oswestry残疾指数和视觉模拟量表-腿部疼痛方面存在显着差异。结论:对于接受腰椎间盘切除术的腰椎间盘突出患者,Barricaid装置可有效减少症状性再突出,但似乎不会改变术后PROMs或再手术率。外科医生必须考虑到器械相关并发症的发生。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Annular Closure Device Reduces Symptomatic Reherniation Rates: Results of a Meta-analysis
Background: The scope of existing annular closure device (ACD) studies examining long-term follow-up data is limited. There is a paucity of studies that report and analyze recent outcomes data following ACD use. Purpose: We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the PubMed, Cochrane, and OVID databases were searched to identify studies after 2015 that include direct evaluation of an ACD in a clinical context with a minimum of 2 years of follow-up and inclusion of reherniation and complication rates, while excluding case reports, reviews, and meta-analyses. Outcome measures included patient demographics, study characteristics, surgical technique, defect measurement technique, perioperative statistics, radiographic assessments, complications, patient-reported outcome measures (PROMs), and postoperative outcomes. Results: Five studies—2 randomized controlled trials (RCTs), 2 retrospective studies, and 1 prospective cohort study—were included. Symptomatic reherniation rates in the ACD populations ranged from 3% to 18.8%. Two studies found that control groups herniate significantly more than their ACD counterparts (ACD 18.8% vs non-ACD 31.6% and ACD 3.33% vs non-ACD 20.0%). No significant differences were found in reoperation rates. Of the 4 studies that reported PROMs data, all observed relative improvement in each cohort, although pooled analysis did not find significant differences between ACD and non-ACD groups for Oswestry Disability Index and visual analogue scale–leg pain at 2-year follow-up. Conclusions: For patients undergoing diskectomy for lumbar disk herniation, the Barricaid device is effective in reducing symptomatic reherniation but does not appear to alter postoperative PROMs or reoperation rates. Surgeons must consider that device-related complications can occur.
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