背景:颈椎椎弓根螺钉内固定是治疗创伤性及非创伤性颈椎失稳及颈椎间盘摘除固定的可靠方法,但其手术风险及置钉失败率仍然较高.目前计算机数字化技术中的数字化导航模板技术在骨科领域的应用存在置钉准确率高及置钉长度误差小的优势.目的:试验观察数字化导航模板技术联合颈椎椎弓根钉植入的有效性及安全性.方法:文章为前瞻性、单中心、自身对照临床试验.试验计划纳入河北省哈励逊国际和平医院颈椎病患者32例,术前采用三维重建颈椎三维模型,设计个性化定制的导航模型,应用3D 打印技术制作导航模板,术中根据术前设计的模型进行颈椎椎弓根螺钉植入,术后根据CT检测结果观察螺钉位置,随访40个月. 试验的主要观察指标为植入后40个月的螺钉位置优良率;次要观察指标为术前、植入后40个月患者目测类比评分、美国脊髓损伤协会(ASIA)损伤分级结果、颈椎X射线及CT图像形态变化及植入后40个月不良反应发生率.试验经河北省哈励逊国际和平医院伦理委员会批准(审批单位:河北省哈励逊国际和平医院,审批号:20120630).研究符合世界医学会制定的《赫尔辛基宣言》的要求.参与者本人对试验方案和过程均知情同意,并签署知情同意书.试验于2017年12月开始进行患者招募,样本及数据收集时间为2017年12月至2019年4月,结果指标分析时间为2020年10月,试验于2020年11月结束.文章结果将以科学会议报告,或在同行评议的期刊上发表传播.试验已在中国临床试验注册中心注册(注册号:ChiCTR-ONC-17013481).讨论:希望通过此试验证实,数字化导航模板技术植入颈椎椎弓根螺钉成功率高,手术操作简便、快捷,植入后疗效及安全性均较好.%BACKGROUND: Cervical pedicle screw fixation is a reliable method for the treatment of traumatic and non-traumatic cervical instability and cervical disc removal and fixation; however, the operation risks and the failure rate of screw insertion are still high. At present, the digital navigation template with digital computer technology, used in the department of orthopedics, has the advantages of accurate screw insertion and a small error in the screw insertion depth. OBJECTIVE: To observe the clinical efficacy and safety of the digital navigation template combined with cervical pedicle screw implantation. METHODS: This is a prospective, single-center, self-controlled, clinical trial. Thirty-two patients with cervical spondylosis will be recruited from the Harrison International Peace Hospital, Hebei Province, China. Before surgery, a three-dimensional (3D) navigation model of the cervical vertebrae will be designed by 3D reconstruction. The navigation template will be generated by 3D printing. The cervical pedicle screws will be implanted according to preoperatively designed models and the screw positions will be observed by computerized tomography (CT) after surgery. The patients will be followed up for 40 months. The primary outcome measure is the excellent and good rate of screw position 40 months after implantation. The secondary outcome measures include the Visual Analog Scale score, American Spinal Injury Association classification, cervical X-ray and CT images before implantation and 40 months after implantation, and the incidence of adverse reactions 40 months after implantation. The protocols have been approved by the Ethics Committee of the Harrison International Peace Hospital in China (approval number: 20120630). The study protocol has been conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association.Written informed consent will be obtained from all participants. The recruitment of subjects will begin in December 2017. Samples and data will be collected from December 2017 to April 2019. Outcome measures will be analyzed in October 2020. This trial will be completed in November 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013481). DISCUSSION: We will verify a high success rate of cervical pedicle screw implantation using the digital navigation template. The operation is simple and quick, with good efficacy and safety.
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