数字化导航辅助颈椎椎弓根螺钉置入提高置钉准确率及安全性:随机对照临床试验方案  

Digital navigation enhances cervical pedicle screw placement accuracy and safety:study protocol of a randomized controlled trial

作　　者：管俊杰[1] 

机构地区：[1]南通大学附属医院,江苏省南通市226001

出　　处：《中国组织工程研究》2016年第39期5898-5903,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:颈椎椎弓根螺钉置入技术目前尚无统一标准,故临床应用效果也无法量化评价。数字化导航技术可为颈椎椎弓根螺钉置入提供定位、定向的参考依据,为椎弓根螺钉植入提供准确安全的保证。目的:观察数字化导航辅助颈椎椎弓根螺钉置入可提高置钉的准确率及安全性。方法:研究为前瞻性、单中心、随机对照、开放性临床试验,将南通大学附属医院骨科住院治疗颈椎骨折患者76例随机分为3组,均经椎弓根螺钉内固定。(1)椎板部分切除置钉组26例(160枚螺钉),采用椎板部分切除置钉法内固定;(2)管道疏通组27例(156枚螺钉),采用管道疏通法内固定;(3)数字化导航技术组23例(162枚螺钉),采用数字化导航技术辅助颈椎经椎弓根螺钉内固定。固定后随访时间为12个月、36个月。方案设计结果的主要结局为固定后12个月各组颈椎椎弓根螺钉穿透程度分级中的Ⅰ级螺钉百分率评价内固定后螺钉植入位置的准确性;次要结局为固定后36个月各组颈椎椎弓根螺钉穿透程度分级中的Ⅰ级螺钉百分率;固定后12个月、36个月患者寰枢间骨性融合率判断颈椎骨折愈合情况;固定前、固定后12个月、36个月各组患者目测类比评分判断患者颈部疼痛情况;固定前、固定后12个月、36个月各组患者以美国脊髓损伤协会损伤分级评价神经功能改善情况;固定后12个月,36个月不良反应发生率评价各种置入方法的安全性。试验经南通大学附属医院医学伦理委员会批准。研究符合世界医学会指定的《赫尔辛基宣言》的标准。参与者对试验内容和治疗过程均知情同意,并签署知情同意书。讨论:研究方案比较了椎弓根螺钉内固定治疗颈椎骨折3种方法的内固定效果,重点观察和比较数字化导航辅助颈椎椎弓根置钉的准确性和安全性,从而为数字化导航技术在临床骨科,尤其是脊柱椎弓根螺钉置入内固�BACKGROUND： A unified standard for cervical pedicle screw placement does not currently exist; therefore, it is difficult to quantitatively evaluate the clinical effects of the technique. Digital navigation can provide a reference for accurate and safe location, orientation, and placement of cervical pedicle screws. OBJECTIVE： To investigate whether digital navigation can greatly increase the accuracy and safety of cervical pedicle screw placement. METHODS： This was a prospective, single-center, randomized controlled, open-label trial. Seventy-six patients with cervical spine fracture scheduled to receive treatment in the Department of Orthopedics, Affiliated Hospital of Nantong University, China were randomly divided into three groups to undergo cervical pedicle screw internal fixation. Patients in the cervical lamina partial excision group（n=26, 160 screws） underwent partial cervical lamina excision and cervical pedicle screw internal fixation; those in the pipeline-dredge discharge group（n=27, 156 screws） underwent pipeline-dredge discharge and cervical pedicle screw internal fixation; and those in the digital navigation group（n=23, 162 screws） underwent digital navigation-assisted cervical pedicle placement. All patients were evaluated at 12 and 36 months. The primary outcome was the percentage of screws graded I when evaluating the penetration degree of the cervical pedicle screws, which evaluates the accuracy of screw placement, 12 months after internal fixation. Secondary outcomes included：（1） the percentage of screws graded I when evaluating the penetration degree of cervical pedicle screws 36 months after internal fixation;（2） bony fusion rate of the atlantoaxial joint, used to evaluate fracture healing, 12 and 36 months after internal fixation;（3） Visual Analogue Scale spine score, used to evaluate cervical neck pain, prior to and 12 and 36 months after internal fixation;（4） American Spinal Injury Association Classification, used to evaluate improvement in neurological

关 键 词：组织工程 颈椎 寰枢关节 骨科植入物 数字化骨科 数字化导航技术 颈椎骨折 椎弓根螺钉 骨性融合 寰枢 不良反应 椎板部分切除 管道疏通 随机对照试验 

分 类 号：R318[医药卫生—生物医学工程]