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RoB 2: a revised tool for assessing risk of bias in randomised trials.《随机对照试验偏倚风险评估工具2:修订版》
BMJ. 2019 Aug 28;366:l4898. doi: 10.1136/bmj.l4898.
2
Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.两级颈椎间盘置换术与颈椎前路椎间盘切除融合术:一项前瞻性、随机、研究性器械豁免临床试验的10年结果
J Neurosurg Spine. 2019 Jun 21;31(4):508-518. doi: 10.3171/2019.4.SPINE19157. Print 2019 Oct 1.
3
Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial.BRYAN 颈椎间盘置换术后 10 年的结果:前瞻性、随机、对照临床试验结果。
Spine (Phila Pa 1976). 2019 May 1;44(9):601-608. doi: 10.1097/BRS.0000000000002907.
4
Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial.选择性受限型SECURE-C颈椎人工椎间盘治疗单节段颈椎间盘疾病的长期临床经验:一项前瞻性、随机、对照的研究性器械豁免临床试验七年随访结果
Int J Spine Surg. 2018 Aug 15;12(3):377-387. doi: 10.14444/5044. eCollection 2018 Jun.
5
Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion.症状性临近节段病需手术治疗:前瞻性、随机、临床试验比较颈椎间盘置换与前路融合术 10 年结果分析。
Neurosurgery. 2019 Feb 1;84(2):347-354. doi: 10.1093/neuros/nyy118.
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Symptomatic adjacent segment disease after single-lever anterior cervical discectomy and fusion: Incidence and risk factors.单节段颈椎前路椎间盘切除融合术后的症状性相邻节段疾病:发病率及危险因素。
Medicine (Baltimore). 2017 Nov;96(47):e8663. doi: 10.1097/MD.0000000000008663.
7
Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up.使用Mobi-C©颈椎间盘进行颈椎间盘置换术的长期评估:一项为期七年随访的随机、前瞻性、多中心临床试验
Int J Spine Surg. 2017 Nov 28;11(4):31. doi: 10.14444/4031. eCollection 2017.
8
Cervical Disc Arthroplasty: Current Evidence and Real-World Application.颈椎间盘置换术:当前证据与实际应用。
Neurosurgery. 2018 Dec 1;83(6):1087-1106. doi: 10.1093/neuros/nyx579.
9
Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.颈椎置换术与颈椎前路椎间盘切除融合术的前瞻性、随机多中心研究:金属对金属人工椎间盘的5年结果
J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.
10
Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial.双节段Prestige LP人工颈椎间盘置换术的长期临床和影像学结果:一项前瞻性随机对照临床试验的结果
J Neurosurg Spine. 2017 Jul;27(1):7-19. doi: 10.3171/2016.11.SPINE16746. Epub 2017 Apr 7.

颈椎间盘置换术与颈椎前路椎间盘切除融合术:对至7年随访时相邻节段手术率的荟萃分析

Cervical disc arthroplasty versus anterior cervical discectomy and fusion: a meta-analysis of rates of adjacent-level surgery to 7-year follow-up.

作者信息

Badhiwala Jetan H, Platt Andrew, Witiw Christopher D, Traynelis Vincent C

机构信息

Division of Neurosurgery and Spinal Program, Department of Surgery, University of Toronto, Toronto, ON, Canada.

Section of Neurosurgery, Department of Surgery, University of Chicago, Chicago, IL, USA.

出版信息

J Spine Surg. 2020 Mar;6(1):217-232. doi: 10.21037/jss.2019.12.09.

DOI:10.21037/jss.2019.12.09
PMID:32309660
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7154351/
Abstract

BACKGROUND

Anterior cervical discectomy and fusion (ACDF) is an effective treatment for cervical spondylosis. A limitation of ACDF is the risk of adjacent-segment degeneration (ASD), owing to arthrodesis of a motion segment. Cervical disc arthroplasty (CDA) has hence garnered significant attention; yet, compelling evidence of reduction in ASD requiring surgery is lacking. This systematic review and meta-analysis sought to compare long-term longitudinal adjacent-level operation rates with CDA versus ACDF.

METHODS

An electronic literature search was conducted. Eligible studies were multi-center randomized controlled trials (RCTs) comparing CDA with ACDF for one- or two-level symptomatic cervical spondylosis. The primary outcome was adjacent-level operation. Index-level reoperation was a secondary outcome. Outcomes were evaluated at 1-year intervals from the index operation to last reported follow-up by random-effects meta-analyses.

RESULTS

Eleven RCTs met criteria. For one-level spondylosis, there was no difference in the rate of adjacent-level operation between CDA (2.3%) and ACDF (3.6%) at 2 years. However, a large difference favoring CDA became evident at 5 years and persisted at 7 years (4.3% 10.8%, P<0.001). Significantly fewer patients who underwent CDA required index-level reoperation at all time points out to 7 years (5.2% 12.7%, P<0.001). Similar to one-level operations, there was no significant difference in adjacent-level operations with two-level CDA (1.7%) versus two-level ACDF (3.4%) at 2 years. At 7 years, a significant difference favoring CDA became apparent (5.1% 10.0%, P=0.014). Two-level CDA resulted in fewer index-level reoperations out to 7 years (4.2% 13.5%, P<0.001).

CONCLUSIONS

In this meta-analysis, the short-term rate of adjacent-level operation was similar with CDA or ACDF. However, around 5 years, a statistically significant divergence emerged, where the rate of adjacent-level surgery rose steeply for ACDF. Index-level reoperations were less frequent with CDA in both the short- and long-term. These data indicate CDA may have a superior longevity to ACDF with regard to need for subsequent adjacent-level operation.

摘要

背景

颈椎前路椎间盘切除融合术(ACDF)是治疗颈椎病的一种有效方法。ACDF的一个局限性是由于运动节段融合,存在相邻节段退变(ASD)的风险。因此,颈椎间盘置换术(CDA)受到了广泛关注;然而,缺乏令人信服的证据表明CDA能降低需要手术的ASD发生率。本系统评价和荟萃分析旨在比较CDA与ACDF的长期纵向相邻节段手术率。

方法

进行电子文献检索。符合条件的研究为多中心随机对照试验(RCT),比较CDA与ACDF治疗单节段或双节段症状性颈椎病的效果。主要结局是相邻节段手术。索引节段再次手术是次要结局。通过随机效应荟萃分析,从索引手术到最后一次报告的随访,每隔1年评估一次结局。

结果

11项RCT符合标准。对于单节段颈椎病,2年时CDA组(2.3%)和ACDF组(3.6%)的相邻节段手术率无差异。然而,在5年时有利于CDA的显著差异变得明显,并在7年时持续存在(4.3%对10.8%,P<0.001)。在7年的所有时间点,接受CDA治疗的患者需要索引节段再次手术的人数显著减少(5.2%对12.7%,P<0.001)。与单节段手术类似,双节段CDA组(1.7%)与双节段ACDF组(3.4%)在2年时的相邻节段手术无显著差异。在7年时,有利于CDA的显著差异变得明显(5.1%对10.0%,P=0.014)。双节段CDA在7年时导致索引节段再次手术的人数减少(4.2%对13.5%,P<0.001)。

结论

在这项荟萃分析中,CDA和ACDF相邻节段手术的短期发生率相似。然而,在大约5年时,出现了统计学上的显著差异,ACDF的相邻节段手术率急剧上升。CDA在短期和长期的索引节段再次手术都较少。这些数据表明,在后续相邻节段手术需求方面,CDA可能比ACDF具有更好的长期效果。