Suri Ikaasa, Ezzat Bahie, Suthakaran Sayahi, Arroyave Villada Juan Sebastian, Kwon Daniel, Martin Lily, Hu James, Yaeger Kurt, Carr Matthew
Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Neurosurgery at Mount Sinai, New York, New York, USA; Illuminant Surgical, Los Angeles, California, USA.
Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Neurosurgery at Mount Sinai, New York, New York, USA.
World Neurosurg. 2025 Feb;194:123550. doi: 10.1016/j.wneu.2024.12.009. Epub 2024 Dec 24.
Three-dimensional (3D) navigation offers real-time guidance in surgery. However, there is limited and inconsistent data regarding the usability, safety, and efficacy. To address gaps in knowledge about 3D navigation in spinal surgery, we conducted a comprehensive review of success rates, complications, revisions, radiation exposure, and operative time associated with Federal and Drug Administration-approved 3D surgical navigation tools.
This study adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and used a protocol registered on International Prospective Registration of Systematic Reviews (CRD42023404554). Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched using relevant keywords for 3D surgical navigation and spinal procedures from 1946 to March 02, 2023. Two independent reviewers assessed the studies using inclusion/exclusion criteria and risk of bias tools. Statistical analyses included one-way analysis of variance, weighted-mean difference, and unpaired t-tests with Welch's correction for associations and comparisons between groups, respectively.
Of the total 11,324 studies identified and 7198 screened, 62 studies totaling 3170 adult patients were included in this comprehensive review. Complication and surgical success rates have remained constant since 2004, with overall rates of 5.5% and 94.0%, respectively. When segmented by spinal region, complication rates may be moderately positively correlated with frequency of cervical and thoracic procedures (r = 0.25, P = 0.68). The most commonly reported complication was pedicle screw malposition or breach. A subset of 20 studies, totaling 1554 patients, compared the performance of 3D navigation to two-dimensional fluoroscopy or freehand navigation. There was a significant difference of 6.53% between surgical success rates of the 3D-navigated and control groups (P = 0.03). However, there was no significant difference in radiation exposure or operative time.
The 3D navigation in spinal procedures has higher surgical success rates than two-dimensional fluoroscopy and freehand navigation. Included studies exhibited varying limitations, including no patient follow-up (n = 1), less than 10 patients (n = 6), various types of spinal disorders (n = 1), and varying comorbidities among participants (n = 2). Improving 3D navigation tools remains imperative to decrease operative time and radiation exposure.
三维（3D）导航为手术提供实时指导。然而，关于其可用性、安全性和有效性的数据有限且不一致。为填补脊柱手术中3D导航知识的空白，我们对与美国食品药品监督管理局（FDA）批准的3D手术导航工具相关的成功率、并发症、翻修手术、辐射暴露和手术时间进行了全面综述。
本研究遵循系统评价和Meta分析的首选报告项目指南，并使用在国际前瞻性系统评价注册库（CRD42023404554）上注册的方案。使用相关关键词在Ovid MEDLINE、Embase和Cochrane对照试验中央注册库数据库中检索1946年至2023年3月2日期间关于3D手术导航和脊柱手术的研究。两名独立评审员使用纳入/排除标准和偏倚风险工具评估研究。统计分析分别包括单因素方差分析、加权平均差以及采用韦尔奇校正的非配对t检验，用于组间关联和比较。
在总共识别出的11324项研究和筛选的7198项研究中，本全面综述纳入了62项研究，共3170例成年患者。自2004年以来，并发症和手术成功率一直保持稳定，总体发生率分别为5.5%和94.0%。按脊柱区域细分时，并发症发生率可能与颈椎和胸椎手术频率呈中度正相关（r = 0.25，P = 0.68）。最常报告的并发症是椎弓根螺钉位置不当或穿破。20项研究（共1554例患者）的一个子集比较了3D导航与二维透视或徒手导航的性能。3D导航组和对照组的手术成功率存在6.53%的显著差异（P = 0.03）。然而，辐射暴露或手术时间没有显著差异。
脊柱手术中的3D导航比二维透视和徒手导航具有更高的手术成功率。纳入的研究存在不同的局限性，包括无患者随访（n = 1）、患者少于10例（n = 6）、脊柱疾病类型多样（n = 1）以及参与者合并症不同（n = 2）。改进3D导航工具对于减少手术时间和辐射暴露仍然至关重要。
