中文摘要：

背景：微创椎弓根螺钉内固定可有效修复胸腰椎疾患,但手术要求术者有熟练的操作技巧,置钉准确,否则术后会出现螺钉脱落等不良反应。3D打印能够为患者制定合适的植入体,对手术修复过程进行准确的模拟,降低手术的难度和复杂性,使植入体与修复的匹配度达到最高。目的：验证3D打印模块辅助腰椎弓根微创置钉能否实现手术的精准定位。方法：研究为单中心、自身对照、开放性、2年随访临床试验方案,在中国福建省莆田市,莆田学院附属医院完成。采集36例腰椎内固定修复病例的术前腰椎薄层CT扫描数据,经Mimics软件数字化三维重建,预设螺钉通过椎弓根的理想钉道,根据钉道周围可剥离骨面解剖结构设计并3D打印带钉道的导航模块。患者手术时在Quadrant系统工作通道中以3D打印模块导引腰椎椎弓根螺钉置入,内固定后再次薄层CT扫描并三维重建。试验的主要观察指标为术中置钉的准确率,评价术前设计3D打印带钉道导航模块与术中实际置钉效果的一致性;试验的次要观察指标为术前和术后6,24个月的腰椎CT成像,手术时间、术中出血量、术中辐射暴露时间,术后6,24个月的不良反应发生率。目前试验的手术部分已完成,结果显示,手术时间（120.58±56.46）min,术中出血量为（136.83±40.62）mL,术中辐射暴露时间为（50±11）s。共置入螺钉186枚,置钉准确率为98%。试验于2016年11月16日在北美临床试验注册中心注册（NCT02970578）;试验经中国福建省莆田学院附属医院伦理委员会批准,研究方案内容符合世界医学会制定的《赫尔辛基宣言》的相关要求;参与试验患者对治疗方案和治疗过程均知情同意,并签署知情同意书,研究从2012年11至2015年11月已开始有患者入组,完成全部数据随访时间为2017年3月。讨论：（1）试验旨在证实3D打印模块可以在脊柱微创管道系统中辅助腰椎?

英文摘要：

BACKGROUND： Minimally invasive pedicle screw fixation is an effective treatment for thoracolumbar diseases, but skilled operations are required during the internal fixation. If inaccurate implantation occurs, adverse reactions will appear postoperatively; for example, the implanted screw will fall off. 3D printing can manufacture a suitable implant for a patient, accurately simulate the repair process, and reduce the difficulty and complexity of the operation, aiming to produce an implant that is most suitable for repair surgery. OBJECTIVE： To verify that precise localization during minimally invasive lumbar pedicle screw placement can be achieved with the assistance of a 3D-printed module.METHODS： A single-center, self-controlled, open-label clinical study with 2-year follow-up was carried out at the Affiliated Hospital of Putian University, Putian, Fujian Province, China. Preoperative thin-layer CT data from 36 cases of lumbar spine fixation were collected and digitally reconstructed using Mimics software. An ideal channel for screw insertion via the vertebral pedicle was preset, and a 3D-printed navigation module with a screw channel was designed and printed based on the anatomical structures of the bone surface that could be stripped around the screw channel. Minimally invasive pedicle screw fixation was then navigated by the 3D-printed module using the Quadrant system. A thin-layer CT scan was used for postoperative three-dimensional reconstruction. The primary outcome measure was accurate rate of screw placement, which was used to assess whether the screw placement under navigation by the 3D-printed module achieved the desired results. Secondary outcome measures included lumbar CT results preoperatively, 6 and 24 months postoperatively, operation time, intraoperative blood loss, duration of radiation exposure, and incidence of adverse events at 6 and 24 months postoperatively. Some results from the completed surgery are given below： the time of operation, amount of bleeding and duration of radiation