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仪器导航对脊柱手术中C型臂辐射及手术时间的影响:一项临床评估

Effect of Instrument Navigation on C-arm Radiation and Time during Spinal Procedures: A Clinical Evaluation.

作者信息

Wang Timothy Y, Hamouda Farah, Mehta Vikram A, Sankey Eric W, Yarbrough Chester, Lark Robert, Abd-El-Barr Muhammad M

机构信息

Duke University Medical Center, Department of Neurological Surgery, Durham, North Carolina.

TrackX Technology, LLC, Chapel Hill, North Carolina.

出版信息

Int J Spine Surg. 2020 Jun 30;14(3):375-381. doi: 10.14444/7049. eCollection 2020 Jun.

Abstract

INTRODUCTION

As minimally invasive spine surgery gains popularity, a focused effort must be made to reduce intraoperative radiation exposure to levels as low as reasonably achievable. Here, we demonstrate the clinical efficacy of a novel technology to aid in instrument navigation that aims to reduce intraoperative radiation exposure, number of fluoroscopic images, and time required to perform the most radiation intensive portions of a multitude of spinal procedures.

METHODS

An internally randomized controlled study was performed over a 1-month period in order to clinically evaluate the effect of the C-arm assisted instrument tracking system, TrackX, on surgeon workflow, time, and radiation emitted. Three surgeons performed multiple spinal procedures on a total of 10 study patients and an additional 3 control patients. The surgeries encompassed minimally invasive spinal techniques and spanned extreme lateral interbody fusion, oblique lumbar interbody fusion, transforaminal lumbar interbody fusion along with percutaneous iliac screw placement, hardware removal, and kyphoplasty. The tasks studied included skin marking, first dilator insertion, localization for hardware placement and hardware removal.

RESULTS

Overall radiation reduction was 83% ( < .0001). Overall reduction in x-rays taken was 78% ( < .0001). Overall time reduction was 81% ( = .0003). Statistical significance held for each surgeon studied and for nearly every procedure type. In these 10 study procedures, over 2 hours of overall operating room time was saved, all while requiring negligible set up time and no system calibration or supplementary x-rays to be taken. There were no adverse outcomes for any study patient, and there was no case where TrackX was not able to successfully complete a given portion of a procedure.

CONCLUSIONS

TrackX instrument navigation is a clinically efficacious and accurate instrument tracking modality. This is the first instrument navigational technology that reduces radiation exposure and images required to complete a procedure while decreasing operative time. TrackX thus allows increased surgical efficiency while increasing operative efficiency and improving intraoperative safety.

LEVEL OF EVIDENCE

摘要

引言

随着微创脊柱手术越来越受欢迎,必须集中精力将术中辐射暴露降低到合理可及的最低水平。在此,我们展示了一种有助于器械导航的新技术的临床疗效,该技术旨在减少术中辐射暴露、透视图像数量以及进行多种脊柱手术中辐射最密集部分所需的时间。

方法

在1个月的时间内进行了一项内部随机对照研究,以临床评估C形臂辅助器械跟踪系统TrackX对外科医生工作流程、时间和辐射的影响。三名外科医生对总共10名研究患者和另外3名对照患者进行了多次脊柱手术。手术包括微创脊柱技术,涵盖极外侧椎间融合术、斜外侧腰椎椎间融合术、经椎间孔腰椎椎间融合术以及经皮髂骨螺钉置入、内固定取出和椎体成形术。研究的任务包括皮肤标记、首次扩张器插入、内固定放置定位和内固定取出。

结果

总体辐射减少了83%(P <.0001)。X线拍摄总数减少了78%(P <.0001)。总体时间减少了81%(P =.0003)。对每位研究的外科医生以及几乎每种手术类型而言,差异均具有统计学意义。在这10例研究手术中,总共节省了超过2小时的手术室时间,同时所需的设置时间可忽略不计,并且无需进行系统校准或额外拍摄X线片。所有研究患者均未出现不良后果,也没有出现TrackX无法成功完成手术给定部分的情况。

结论

TrackX器械导航是一种临床有效且准确的器械跟踪方式。这是第一种在减少完成手术所需的辐射暴露和图像数量的同时,还能缩短手术时间的器械导航技术。因此,TrackX在提高手术效率的同时,增强了手术效能并改善了术中安全性。

证据等级

2级。

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