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机器人辅助与透视引导下经椎间孔腰椎体间融合术(TLIF)治疗腰椎退行性疾病的比较:随机对照试验和队列研究的系统评价和荟萃分析。

Comparison of robot-assisted versus fluoroscopy-guided transforaminal lumbar interbody fusion (TLIF) for lumbar degenerative diseases: a systematic review and meta-analysis of randomized controlled trails and cohort studies.

机构信息

Honghui-Hospital, Xi'an Jiaotong University, Xi'an, 710054, China.

Shannxi Key Laboratory of Spine Bionic Treatment, Xi'an, China.

出版信息

Syst Rev. 2024 Jul 5;13(1):170. doi: 10.1186/s13643-024-02600-6.

Abstract

BACKGROUND

As an emerging technology in robot-assisted (RA) surgery, the potential benefits of its application in transforaminal lumbar interbody fusion (TLIF) lack substantial support from current evidence.

OBJECTIVE

We aimed to investigate whether the RA TLIF is superior to FG TLIF in the treatment of lumbar degenerative disease.

METHODS

We systematically reviewed studies comparing RA versus FG TLIF for lumbar degenerative diseases through July 2022 by searching PubMed, Embase, Web of Science, CINAHL (EBSCO), Chinese National Knowledge Infrastructure (CNKI), WanFang, VIP, and the Cochrane Library, as well as the references of published review articles. Both cohort studies (CSs) and randomized controlled trials (RCTs) were included. Evaluation criteria included the accuracy of percutaneous pedicle screw placement, proximal facet joint violation (FJV), radiation exposure, duration of surgery, estimated blood loss (EBL), and surgical revision. Methodological quality was assessed using the Cochrane risk of bias and ROBINS-I Tool. Random-effects models were used, and the standardized mean difference (SMD) was employed as the effect measure. We conducted subgroup analyses based on surgical type, the specific robot system used, and the study design. Two investigators independently screened abstracts and full-text articles, and the certainty of evidence was graded using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.

RESULTS

Our search identified 539 articles, of which 21 met the inclusion criteria for quantitative analysis. Meta-analysis revealed that RA had 1.03-folds higher "clinically acceptable" accuracy than FG (RR: 1.0382, 95% CI: 1.0273-1.0493). And RA had 1.12-folds higher "perfect" accuracy than FG group (RR: 1.1167, 95% CI: 1.0726-1.1626). In the case of proximal FJV, our results indicate a 74% reduction in occurrences for patients undergoing RA pedicle screw placement compared to those in the FG group (RR: 0.2606, 95%CI: 0.2063- 0.3293). Seventeen CSs and two RCTs reported the duration of time. The results of CSs suggest that there is no significant difference between RA and FG group (SMD: 0.1111, 95%CI: -0.391-0.6131), but the results of RCTs suggest that the patients who underwent RA-TLIF need more surgery time than FG (SMD: 3.7213, 95%CI: 3.0756-4.3669). Sixteen CSs and two RCTs reported the EBL. The results suggest that the patients who underwent RA pedicle screw placement had fewer EBL than FG group (CSs: SMD: -1.9151, 95%CI: -3.1265-0.7036, RCTs: SMD: -5.9010, 95%CI: -8.7238-3.0782). For radiation exposure, the results of CSs suggest that there is no significant difference in radiation time between RA and FG group (SMD: -0.5256, 95%CI: -1.4357-0.3845), but the patients who underwent RA pedicle screw placement had fewer radiation dose than FG group (SMD: -2.2682, 95%CI: -3.1953-1.3411). And four CSs and one RCT reported the number of revision case. The results of CSs suggest that there is no significant difference in the number of revision case between RA and FG group (RR: 0.4087,95% CI 0.1592-1.0495). Our findings are limited by the residual heterogeneity of the included studies, which may limit the interpretation of the results.

CONCLUSION

In TLIF, RA technology exhibits enhanced precision in pedicle screw placement when compared to FG methods. This accuracy contributes to advantages such as the protection of adjacent facet joints and reductions in intraoperative radiation dosage and blood loss. However, the longer preoperative preparation time associated with RA procedures results in comparable surgical duration and radiation time to FG techniques. Presently, FG screw placement remains the predominant approach, with clinical surgeons possessing greater proficiency in its application. Consequently, the integration of RA into TLIF surgery may not be considered the optimal choice.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42023441600.

摘要

背景

作为机器人辅助(RA)手术中的一项新兴技术,其在经椎间孔腰椎体间融合术(TLIF)中的应用的潜在益处尚未得到当前证据的充分支持。

目的

我们旨在研究 RA TLIF 在治疗腰椎退行性疾病方面是否优于 FG TLIF。

方法

我们通过检索 PubMed、Embase、Web of Science、CINAHL(EBSCO)、中国知网(CNKI)、万方、维普、Cochrane 图书馆以及已发表综述文章的参考文献,系统地回顾了截至 2022 年 7 月比较 RA 与 FG TLIF 治疗腰椎退行性疾病的研究。纳入了队列研究(CSs)和随机对照试验(RCTs)。评估标准包括经皮椎弓根螺钉放置的准确性、近端关节突关节侵犯(FJV)、辐射暴露、手术时间、估计失血量(EBL)和手术翻修。使用 Cochrane 偏倚风险和 ROBINS-I 工具评估方法学质量。采用随机效应模型,采用标准化均数差(SMD)作为效应量。我们根据手术类型、具体机器人系统和研究设计进行了亚组分析。两位研究者独立筛选摘要和全文文章,并使用 GRADE(推荐评估、制定和评估分级)方法对证据质量进行分级。

结果

我们的搜索共确定了 539 篇文章,其中 21 篇符合定量分析的纳入标准。Meta 分析显示,RA 比 FG 具有 1.03 倍更高的“临床可接受”准确性(RR:1.0382,95%CI:1.0273-1.0493)。RA 比 FG 组具有 1.12 倍更高的“完美”准确性(RR:1.1167,95%CI:1.0726-1.1626)。在近端 FJV 方面,我们的结果表明,与 FG 组相比,RA 椎弓根螺钉置入的患者发生近端 FJV 的几率降低了 74%(RR:0.2606,95%CI:0.2063-0.3293)。17 项 CSs 和 2 项 RCT 报告了手术时间。CSs 的结果表明,RA 组和 FG 组之间的手术时间没有显著差异(SMD:0.1111,95%CI:-0.391-0.6131),但 RCTs 的结果表明,接受 RA-TLIF 的患者需要比 FG 组更多的手术时间(SMD:3.7213,95%CI:3.0756-4.3669)。16 项 CSs 和 2 项 RCT 报告了估计失血量。结果表明,接受 RA 椎弓根螺钉置入的患者的估计失血量比 FG 组少(CSs:SMD:-1.9151,95%CI:-3.1265-0.7036,RCTs:SMD:-5.9010,95%CI:-8.7238-3.0782)。对于辐射暴露,CSs 的结果表明,RA 组和 FG 组之间的辐射时间没有显著差异(SMD:-0.5256,95%CI:-1.4357-0.3845),但接受 RA 椎弓根螺钉置入的患者的辐射剂量比 FG 组少(SMD:-2.2682,95%CI:-3.1953-1.3411)。4 项 CSs 和 1 项 RCT 报告了翻修例数。CSs 的结果表明,RA 组和 FG 组的翻修例数没有显著差异(RR:0.4087,95% CI 0.1592-1.0495)。我们的研究结果受到纳入研究的残余异质性的限制,这可能限制了结果的解释。

结论

在 TLIF 中,与 FG 方法相比,RA 技术在椎弓根螺钉放置方面具有更高的准确性。这种准确性有助于保护相邻的关节突关节,并减少术中辐射剂量和失血量。然而,RA 手术程序的术前准备时间较长导致手术时间和辐射时间与 FG 技术相当。目前,FG 螺钉放置仍然是主要方法,临床外科医生在其应用方面具有更高的熟练度。因此,RA 技术整合到 TLIF 手术中可能不是最佳选择。

系统评价注册

PROSPERO CRD42023441600。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d775/11227242/020c2e41a3d4/13643_2024_2600_Fig1_HTML.jpg

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