Dalal Sidhant, Araghi Kasra, Mai Eric, Maayan Omri, Shafi Karim, Shahi Pratyush, Shinn Daniel, Song Junho, Gang Catherine Himo, Iyer Sravisht, Qureshi Sheeraz
Hospital for Special Surgery, New York, NY, USA.
Weill Cornell Medical College, New York, NY, USA.
HSS J. 2025 Feb;21(1):55-64. doi: 10.1177/15563316231215796. Epub 2023 Dec 7.
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. We sought to summarize the available long-term follow-up data on postoperative outcomes of the Barricaid (Intrinsic Therapeutics) ACD. 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. 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. 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.
现有关于环形闭合装置（ACD）的长期随访数据研究范围有限。报告和分析使用ACD后近期疗效数据的研究较少。我们试图总结Barricaid（Intrinsic Therapeutics）ACD术后疗效的可用长期随访数据。按照系统评价和Meta分析的首选报告项目指南，检索了PubMed、Cochrane和OVID数据库，以识别2015年后的研究，这些研究包括在临床背景下对ACD进行直接评估，随访至少2年，并纳入复发率和并发症发生率，同时排除病例报告、综述和Meta分析。结局指标包括患者人口统计学特征、研究特点、手术技术、缺损测量技术、围手术期统计数据、影像学评估、并发症、患者报告结局指标（PROMs）和术后结局。纳入了五项研究，其中两项为随机对照试验（RCT）、两项为回顾性研究和一项前瞻性队列研究。ACD组的症状性复发率在3%至18.8%之间。两项研究发现，对照组的疝出明显多于使用ACD的对应组（ACD组为18.8%，非ACD组为31.6%；ACD组为3.33%，非ACD组为20.0%）。再次手术率未发现显著差异。在报告PROMs数据的4项研究中，所有研究均观察到各队列均有相对改善，尽管汇总分析未发现ACD组和非ACD组在2年随访时的Oswestry功能障碍指数和视觉模拟量表腿痛方面存在显著差异。对于因腰椎间盘突出症接受椎间盘切除术的患者，Barricaid装置在降低症状性复发方面有效，但似乎不会改变术后PROMs或再次手术率。外科医生必须考虑到可能发生与装置相关的并发症。
