Hubbe Ulrich, Sircar Ronen, Scheiwe Christian, Scholz Christoph, Kogias Evangelos, Krüger Marie Therese, Volz Florian, Klingler Jan-Helge
Department of Neurosurgery, Freiburg University Medical Center, Breisacher Str. 64, D-79106, Freiburg, Germany.
Trials. 2015 Apr 9;16:142. doi: 10.1186/s13063-015-0690-5.
Some symptomatic degenerative conditions of the lumbar spine may be treated with spinal fusion if conservative treatment has failed. The minimally invasive technique of transforaminal lumbar interbody fusion (MIS TLIF) is increasingly used but has been found to generate increased radiation exposure to the patient and staff. Modern three-dimensional (3D) C-arm devices are capable of providing conventional two-dimensional fluoroscopic images (x-rays) as well as 3D image sets for intraoperative navigation. This study was designed to compare the radiation exposure between these two intraoperative imaging techniques in MIS TLIF procedures.
This study is a randomized controlled trial. Forty participants scheduled to undergo monosegmental MIS TLIF will be recruited and randomly allocated to one of two groups with respect to the applied intraoperative imaging technique: conventional fluoroscopy (FLUORO group) and 3D fluoroscopy-based navigation combined with conventional fluoroscopy (NAV group). Furthermore, patients scheduled to undergo bisegmental MIS TLIF during the recruitment period for monosegmental MIS TLIF will be assessed for eligibility and will be randomly assigned separately. The primary endpoint is the radiation exposure to the surgeon and is measured by dosimeter readings. Secondary endpoints are the radiation exposure to the assistant surgeon, scrub nurse, anesthetist, patient, and C-arm as well as radiation exposure in relation to the body mass index of the patient.
Results of this randomized study will help to compare the radiation exposure to the operating staff and patient during MIS TLIF procedures using conventional fluoroscopy versus 3D fluoroscopy-based navigation combined with conventional fluoroscopy. Furthermore, recommendations regarding the appropriate use of the investigated intraoperative imaging techniques will be made to improve radiation protection and to reduce radiation exposure.
Registration number of the German Clinical Trials Register: DRKS00004514 . Registration date: 11 August 2012.
如果保守治疗失败，一些有症状的腰椎退行性疾病可通过脊柱融合术治疗。经椎间孔腰椎椎体间融合术（MIS TLIF）这一微创技术的使用日益增多，但已发现会增加患者和工作人员的辐射暴露。现代三维（3D）C形臂设备能够提供传统的二维荧光透视图像（X射线）以及用于术中导航的3D图像集。本研究旨在比较MIS TLIF手术中这两种术中成像技术的辐射暴露情况。
本研究为随机对照试验。计划接受单节段MIS TLIF手术的40名参与者将被招募，并根据所应用的术中成像技术随机分配到两组之一：传统荧光透视组（FLUORO组）和基于3D荧光透视的导航联合传统荧光透视组（NAV组）。此外，在单节段MIS TLIF招募期间计划接受双节段MIS TLIF手术的患者将接受资格评估，并将单独随机分配。主要终点是外科医生的辐射暴露，通过剂量计读数测量。次要终点是助理外科医生、刷手护士、麻醉师、患者和C形臂的辐射暴露以及与患者体重指数相关的辐射暴露。
这项随机研究的结果将有助于比较在MIS TLIF手术中使用传统荧光透视与基于3D荧光透视的导航联合传统荧光透视时，手术人员和患者的辐射暴露情况。此外，将对所研究的术中成像技术的适当使用提出建议，以改善辐射防护并减少辐射暴露。
德国临床试验注册中心注册号：DRKS00004514。注册日期：2012年8月11日。
