Meta-analysis on interspinous dynamic stabilization system Wallis versus Coflex for lumbar degenerative disease

doi:10.3969/j.issn.2095-4344.2017.11.027

Abstract

Abstract:

BACKGROUND: It is still controversial that interspinous dynamic stabilization system Wallis and Coflex which one can provide better clinical effects for lumbar degenerative disease.

OBJECTIVE: To systematically assess the clinical effectiveness and safety of Wallis and Coflex for lumbar degenerative disease.

METHODS: According to the computer-based online search of PubMed, Embase, Medline, Cochrane Library, CBM, CNKI, Wanfang Database, and VIP, articles published before August 1^st, 2016 were searched. Articles about Wallis comparing with Coflex for lumbar degenerative disease were included; the quality score of methodology was assessed by MINORS. Research data abstracted and synthesized by Review Manager 5.3 were used for meta-analysis.

RESULTS AND CONCLUSION: (1) Six studies were included, and all studies were designed for non-randomized controlled trial. (2) There were no significant statistical differences in Japanese Orthopedic Association, Oswestry disability index, visual analogue scale score, Prolo functional score, segmental lordosis angle, and segment movement degree. Incidence of adverse events was significantlue scale less in the Wallis group than in the Conflex group (P < 0.05). (3) There was no significant difference in clinical efficacy between Wallis and Coflex in the early and mid-term follow-up. We can conclude that Wallis may provide better clinical safety than Coflex.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Lumbar Vertebrae, Intervertebral Disk Degeneration, Meta-Analysis, Tissue Engineering

CLC Number:

R318

Zhao He, Yu Xing, Tang Xiang-sheng, He Feng, Yang Yong-dong, Xiong Yang, Hu Zhen-guo, Xu Lin. Meta-analysis on interspinous dynamic stabilization system Wallis versus Coflex for lumbar degenerative disease [J]. Chinese Journal of Tissue Engineering Research, 2017, 21(11): 1798-1804.

Figures/Tables 4

2.2 纳入文献的质量评价纳入文献的方法学质量由适用于外科非随机对照干预性研究的MINORS量表评价，2篇文献的研究质量评分均在18分，4篇文献的研究质量评分均在16分，见表1。所有纳入研究均有明确的纳入和排除标准。纳入的6篇研究均为非随机对照试验。由于外科手术临床试验的的特殊性。6篇研究均未进行盲法评估。 2.3 术后疗效比较 2.3.1 JOA评分共4项研究报道了术后14.6，30.4，31.8，64.6个月随访时JOA评分改变情况[7，9，11-12]，纳入患者588例，Wallis组246例，Coflex组342例。各研究间具有统计学异质性(P=0.006，I2=76%)，I2 > 50%，故采用随机效应模型进行系统评价。分析结果示，在术后14.6，30.4，31.8，64.6个月随访JOA评分改变时，2组比较差异无显著性意义[WMD=0.41，95%CI(-0.58，1.41)，P=0.41]，见图2。 2.3.2 Oswestry残障指数共4项研究报道了术后14.6，20-25，31.8，64.6个月随访时Oswestry残障指数改变情况[7-8，11-12]，纳入患者588例，Wallis组241例，Coflex组347例。各研究间具有统计学异质性(P=0.01，I2=72%)，I2 > 50%，故采用随机效应模型进行系统评价。分析结果示，在术后14.6，20-25，31.8，64.6个月随访Oswestry残障指数改变时，2组比较差异无显著性意义[WMD=-2.41，95%CI(-5.44，0.61)，P=0.12]，见图3。 2.3.3 目测类比评分共5项研究报道了术后14.6，20-25，30.4-31.8，64.6个月随访时目测类比评分改变情况[7-9，11-12]，纳入患者640例，Wallis组266例，Coflex组374例。各研究间具有统计学异质性(P=0.02，I2=67%)，I2 > 50%，故采用随机效应模型进行系统评价。分析结果示，在术后14.6，20-25，30.4-31.8，64.6个月随访目测类比评分改变时，2组比较差异无显著性意义[WMD=-0.06，95%CI(-0.41，0.28)，P=0.72]，见图4。 2.3.4 不良事件共5项研究报道了术后随访不良事件情况[7，9-12]，纳入患者756例，Wallis组376例，Coflex组380例。各研究间具无统计学异质性(P=0.24，I2=31%)，I2 < 50%，故采用固定效应模型进行系统评价。分析结果示，在术后随访不良事件时，2组比较差异有显著性意义[OR=0.22，95%CI(0.09，0.53)，P=0.000 9]，见图5。"

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