Department of Orthopedic Surgery, The First Hospital of China Medical University, No.155, Nanjing Bei Street, Shenyang, 110001, People's Republic of China.
Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, No.36, Sanhao Street, Shenyang, 110001, People's Republic of China.
Eur Spine J. 2023 Jul;32(7):2377-2386. doi: 10.1007/s00586-023-07629-0. Epub 2023 Apr 3.
The objective of this study was to systematically estimate the effectiveness and safety of annulus closure device (ACD) implantation in discectomy for patients with lumbar disc herniation (LDH).
A systematic search was performed on PubMed, EMBASE and the Cochrane Library for randomized controlled trial (RCT) from inception until April 16, 2022. Trials which investigated comparisons between with and without ACD implantation in discectomy for LDH patients were identified.
In total, five RCTs involving 2380 patients with LDH underwent discectomy were included. The included patients were divided into ACD group and control group (CTL). Significant differences were found in the rate of re-herniation (ACD: 7.40%, CTL: 17.58%), reoperation (ACD: 5.39%, CTL: 13.58%) and serious adverse event (ACD: 10.79%, CTL: 17.14%) between ACD group and CTL group. No significant difference was found in VAS-BACK, VAS-LEG, ODI and SF-12 PCS between ACD and CTL. The surgical time of ACD was longer than CTL with statistical significance. In subgroup analyses based on discectomy type, significant differences were found in the rate of re-herniation (ACD: 10.73%, CTL: 21.27%), reoperation (ACD: 4.96%, CTL: 13.82%) and serious adverse event (ACD: 7.59%, CTL: 16.89%) between ACD and CTL in limited lumbar discectomy (LLD).
Discectomy either with or without ACD implantation is considered to achieve similar clinical outcomes. Whereas, the ACD implantation in LLD is associated with lower re-herniation and reoperation rate but prolonged surgical time for LDH patients. Researches on cost-effectiveness and effect of ACD implantation in different discectomy are needed in the future.
本研究旨在系统评估椎间盘切除术治疗腰椎间盘突出症（LDH）患者时使用环锯闭合装置（ACD）的有效性和安全性。
对 PubMed、EMBASE 和 Cochrane 图书馆进行了系统检索，检索时间从建库至 2022 年 4 月 16 日，纳入比较 LDH 患者椎间盘切除术中使用与不使用 ACD 植入物的随机对照试验（RCT）。
共纳入 5 项 RCT，共 2380 例 LDH 行椎间盘切除术患者。纳入患者分为 ACD 组和对照组（CTL）。ACD 组的再突出率（ACD：7.40%，CTL：17.58%）、再手术率（ACD：5.39%，CTL：13.58%）和严重不良事件（ACD：10.79%，CTL：17.14%）均低于 CTL 组，差异有统计学意义。ACD 组和 CTL 组在 VAS-BACK、VAS-LEG、ODI 和 SF-12 PCS 方面差异无统计学意义。ACD 组的手术时间长于 CTL，差异有统计学意义。基于椎间盘切除术类型的亚组分析发现，在有限腰椎间盘切除术（LLD）中，ACD 组与 CTL 组的再突出率（ACD：10.73%，CTL：21.27%）、再手术率（ACD：4.96%，CTL：13.82%）和严重不良事件（ACD：7.59%，CTL：16.89%）差异有统计学意义。
对于 LDH 患者，椎间盘切除术联合或不联合 ACD 植入物均可获得相似的临床结果。然而，在 LLD 中，ACD 植入物与较低的再突出率和再手术率相关，但手术时间延长。未来需要进行关于不同椎间盘切除术的 ACD 植入物的成本效益和效果的研究。
