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与双侧椎弓根螺钉固定相比,单侧椎弓根螺钉固定在治疗2级腰椎退行性疾病的腰椎融合手术中安全性如何?随机对照试验的Meta分析。

How Safe Is Unilateral Pedicle Screw Fixation in Lumbar Fusion Surgery for Management of 2-Level Lumbar Degenerative Disorders Compared with Bilateral Pedicle Screw Fixation? Meta-analysis of Randomized Controlled Trials.

作者信息

Muthu Sathish, Chellamuthu Girinivasan

机构信息

Government Hospital, Velayuthampalayam, Karur, Tamil Nadu, India; Orthopaedic Research Group, Coimbatore, Tamil Nadu, India.

Fellow of Orthopedic Trauma Surgery, Ganga Hospitals, Coimbatore, Tamil Nadu, India; Orthopaedic Research Group, Coimbatore, Tamil Nadu, India.

出版信息

World Neurosurg. 2020 Aug;140:357-368. doi: 10.1016/j.wneu.2020.05.078. Epub 2020 May 16.

Abstract

OBJECTIVE

We performed this meta-analysis to compare the safety of unilateral with bilateral instrumented fusion in 2-level degenerative disorders of the lumbar spine.

METHODS

We conducted an independent and a duplicate electronic database search including PubMed, Embase, and Cochrane Library until January 2020 for randomized controlled trials (RCTs) comparing unilateral pedicle screw fixation with bilateral pedicle screw fixation for multilevel lumbar degenerative disorders. Fusion and complication rates were the primary outcomes analyzed. Analysis was performed in R platform using OpenMeta[Analyst] software.

RESULTS

Five RCTs including 215 patients (Unilateral/Bilateral = 106/109) were included in the meta-analysis. There was no significant difference between the 2 groups regarding fusion rate, complication rate, blood loss, duration of hospital stay, functional outcome scores like Visual Analog Scale, Oswestry Disability Index, and Short-Form 36 health survey at the final follow-up. Unilateral pedicle screw fixation was associated with a significant reduction in operation time (P < 0.001). Compared with the open approach, the minimally invasive approach showed a significant difference in terms of factors like operative time, blood loss, hospital stay, Visual Analog Scale, and Oswestry Disability Index (P = 0.004).

CONCLUSIONS

Our meta-analysis establishes the immediate safety and significant lesser operative period of unilateral pedicle screw fixation in lumbar fusion. However, due to lack of evidence on complications like cage subsidence and adjacent segment disease, unilateral pedicle screw fixation cannot be recommended as an alternative to bilateral pedicle screw fixation for 2-level degenerative spinal disease. Our analysis established the lacunae in literature for high-quality evidence on the subject; hence we recommend further large multicenter studies with longer follow-up to arrive at a conclusion.

摘要

目的

我们进行这项荟萃分析,以比较单侧与双侧器械融合术在2级腰椎退行性疾病中的安全性。

方法

我们进行了独立和重复的电子数据库检索,包括PubMed、Embase和Cochrane图书馆,直至2020年1月,以查找比较单侧椎弓根螺钉固定与双侧椎弓根螺钉固定治疗多节段腰椎退行性疾病的随机对照试验(RCT)。融合率和并发症发生率是分析的主要结局指标。使用OpenMeta[Analyst]软件在R平台上进行分析。

结果

荟萃分析纳入了5项RCT,共215例患者(单侧/双侧 = 106/109)。在末次随访时,两组在融合率、并发症发生率、失血量、住院时间、功能结局评分(如视觉模拟评分、Oswestry功能障碍指数和简短健康调查问卷36项)方面无显著差异。单侧椎弓根螺钉固定与手术时间显著缩短相关(P < 0.001)。与开放手术相比,微创方法在手术时间、失血量、住院时间、视觉模拟评分和Oswestry功能障碍指数等因素方面有显著差异(P = 0.004)。

结论

我们的荟萃分析证实了单侧椎弓根螺钉固定在腰椎融合术中的即时安全性以及显著更短的手术时间。然而,由于缺乏关于椎间融合器下沉和相邻节段疾病等并发症的证据,对于2级退行性脊柱疾病,不建议将单侧椎弓根螺钉固定作为双侧椎弓根螺钉固定的替代方法。我们的分析揭示了该主题高质量证据在文献中的空白;因此,我们建议进一步开展大型多中心研究,并进行更长时间的随访以得出结论。

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