Effect of industry funding on outcome reporting in cervical disc arthroplasty: a systematic review and meta-analysis of randomized controlled trials.

IF 4.9 1区 医学 Q1 CLINICAL NEUROLOGY
Athan G Zavras, Jonathan R Acosta, Hareindra R Jeyamohan, Garrett M Breyer, Kyle J Holmberg, Boyle C Cheng, Daniel T Altman, Ryan D Sauber
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引用次数: 0

Abstract

Background context: Cervical Disc Arthroplasty (CDA) has been shown to be an effective and safe alternative to Anterior Cervical Discectomy and Fusion (ACDF), with randomized controlled trials (RCTs) reporting non-inferior or even favorable outcomes to ACDF. However, the current literature of large RCTs reporting long-term outcomes of CDA primarily comprises of the industry sponsored Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials. As a result, CDA has yet to be universally accepted by surgeons due to concerns of bias in the current literature.

Purpose: To compare the outcomes of single-level CDA and ACDF by conducting a meta-analysis of RCTs, with a subgroup comparison of IDE and non-IDE trial results.

Study design: Systematic review and meta-analysis.

Patient sample: 19 studies (9 IDE, 10 non-IDE) reporting the outcomes of 18 RCTs were included with a total of 3054 patients (1691 CDA and 1363 ACDF). Among CDA patients, 1229 (72.7%) were enrolled in an FDA IDE trial, while 462 (27.3%) were involved in RCTs that were not funded by industry. Minimum follow-up among the RCTs included ranged from 2 to 10 years.

Outcome measures: Outcomes of interest included index and adjacent segment reoperation rates, postoperative disability as reported by the Neck Disability Index (NDI), and the Visual Analog Scale (VAS) for Neck and Arm pain.

Methods: A random effects meta-analysis was performed comparing CDA and ACDF by pooling the outcomes of all RCTs for each outcome of interest. A subgroup analysis was then performed comparing the pooled outcomes of the FDA IDE trials and non-IDE RCTs. Standardized mean differences (SMD) and log relative risk (RR) were used to analyze continuous and categorical variables with corresponding 95% confidence intervals (CI).

Results: Among all RCTs, there was a significantly lower risk for all secondary surgical interventions with CDA relative to ACDF (RR: 0.91, 95% CI: 0.55-1.28; p < 0.0001) in addition to lower risk for adjacent segment surgery (RR: 1.06, 95% CI: 0.66-1.45; p < 0.0001), and index segment reoperation (RR: 0.48, 95% CI: 0.005-0.96; p=.048). No significant differences in NDI, VAS Neck, or VAS Arm were found in the analyses comparing ACDF and CDA (p>.05). When comparing between the IDE and non-IDE trial subgroups, there were no significant differences noted in any assessed outcome (p>.05).

Conclusion: Cervical disc arthroplasty appears to be equivalent to ACDF in reducing postoperative pain and disability, while also potentially decreasing the risk for subsequent surgical intervention, as demonstrated by the FDA IDE trials and non-IDE RCTs without industry ties. While a large number of high-quality trials for CDA do pose a risk for bias due to industry sponsorship, the current literature of high-quality RCTs without industry affiliations corroborates similar findings.

行业资助对颈椎椎间盘置换术疗效报告的影响:随机对照试验的系统回顾和荟萃分析。
背景:颈椎间盘置换术(CDA)已被证明是一种有效和安全的替代前路颈椎间盘切除术和融合(ACDF)的方法,随机对照试验(RCTs)报告了ACDF的不差甚至有利的结果。然而,目前报道CDA长期结果的大型随机对照试验文献主要包括行业赞助的食品和药物管理局(FDA)研究器械豁免(IDE)试验。因此,由于目前文献中存在偏见,CDA尚未被外科医生普遍接受。目的:通过对随机对照试验进行荟萃分析,比较单水平CDA和ACDF的结局,并对IDE和非IDE试验结果进行亚组比较。研究设计:系统评价和荟萃分析。患者样本:19项研究(9项IDE, 10项非IDE)报告了18项rct的结果,共纳入3054例患者(1691例CDA和1363例ACDF)。在CDA患者中,1229名(72.7%)患者参加了FDA IDE试验,而462名(27.3%)患者参加了非行业资助的随机对照试验。纳入的随机对照试验的最短随访时间为2-10年。结果测量:感兴趣的结果包括指数和邻近节段再手术率,颈部残疾指数(NDI)报告的术后残疾,以及颈部和手臂疼痛的视觉模拟评分(VAS)。方法:采用随机效应荟萃分析比较CDA和ACDF,将所有rct的结果汇总到每个感兴趣的结果中。然后进行亚组分析,比较FDA IDE试验和非IDE随机对照试验的合并结果。采用标准化平均差异(SMD)和对数相对风险(RR)对连续变量和分类变量进行分析,并给出相应的95%置信区间(CI)。结果:在所有随机对照试验中,与ACDF相比,CDA的所有二次手术干预的风险显著降低(RR: 0.91, 95% CI: 0.55 - 1.28;p < 0.0001),邻段手术的风险也较低(RR: 1.06, 95% CI: 0.66 - 1.45;p < 0.0001),指数段再手术(RR: 0.48, 95% CI: 0.005 ~ 0.96; = 0.048页)。在比较ACDF和CDA的分析中,NDI、VAS颈部、VAS臂均无显著差异(p < 0.05)。当比较IDE和非IDE试验亚组时,任何评估结果均无显著差异(p < 0.05)。结论:经FDA IDE试验和无行业关联的非IDE随机对照试验证实,颈椎间盘置换术在减少术后疼痛和残疾方面与ACDF相当,同时也可能降低后续手术干预的风险。虽然大量高质量的CDA试验确实由于行业赞助而存在偏倚风险,但目前无行业关联的高质量随机对照试验文献证实了类似的发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Spine Journal
Spine Journal 医学-临床神经学
CiteScore
8.20
自引率
6.70%
发文量
680
审稿时长
13.1 weeks
期刊介绍: The Spine Journal, the official journal of the North American Spine Society, is an international and multidisciplinary journal that publishes original, peer-reviewed articles on research and treatment related to the spine and spine care, including basic science and clinical investigations. It is a condition of publication that manuscripts submitted to The Spine Journal have not been published, and will not be simultaneously submitted or published elsewhere. The Spine Journal also publishes major reviews of specific topics by acknowledged authorities, technical notes, teaching editorials, and other special features, Letters to the Editor-in-Chief are encouraged.
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