微创后路经皮椎弓根螺钉内固定修复单纯前中柱损伤的急性胸腰椎骨折:回顾性、自身前后对照临床试验方案  

Posterior percutaneous pedicle screw fixation for acute thoracolumbar vertebral fractures with simple anterior spinal column injury: study protocol for a retrospective, self-controlled trial

作　　者：梁磊[1] 刘文德[1] 吴一凡[1] 孙小航[1] 丁俊杰[1] 

机构地区：[1]郑州市第153中心医院全军创伤骨科中心脊柱外科,河南省郑州市450042

出　　处：《中国组织工程研究》2016年第48期7267-7272,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:后路切开椎弓根钉内固定是临床胸腰椎骨折的主要修复方式之一,但其存在术中创伤大、出血多、术中及固定后康复时间长,部分患者固定后长期存在顽固性腰背部僵硬与腰痛的缺陷。经皮椎弓根螺钉进行脊柱骨折外固定时,可减少置钉对椎旁肌的过度损伤,尤其对单纯前中柱损伤的急性胸腰椎压缩性骨折的修复效果较好。为此,试验假设以微创后路经皮椎弓根螺钉内固定修复单纯前中柱损伤的急性胸腰椎骨折有较好的疗效。目的:回顾性分析微创后路经皮椎弓根螺钉内固定修复单纯前中柱损伤的急性胸腰椎骨折的疗效。方法:研究为回顾性、单中心、自身前后对照的临床试验,在中国河南省,郑州市第153中心医院完成。纳入试验的单纯前中柱损伤的急性胸腰椎骨折患者共32例,平均34.7岁,男22例,女10例,均采用微创后路经皮椎弓根螺钉内固定修复,随访3个月。试验的主要观察指标为固定前、固定后即刻、固定后3个月患者的伤椎的Cobb角,以观察胸腰椎弯曲程度。试验的次要观察指标为固定前、固定后即刻、末次随访患者的伤椎前缘高度、X射线片形态以评价胸腰椎骨折的恢复情况;患者手术时间、术中出血量、住院时间;其他观察指标为固定后3个月患者不良反应发生率。试验经中国河南省郑州市第153中心医院伦理委员会批准。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对治疗方案和过程均知情同意,并签署知情同意书。试验于2016年11月10日在北美临床试验注册中心作回顾性分析注册(NCT02963571)。讨论:试验旨在证实微创后路经皮椎弓根螺钉内固定治疗单纯前中柱损伤的急性胸腰椎骨折具有确切疗效,并提供长期随访的客观数据。BACKGROUND： Posterior pedicle screw fixation is commonly used for thoracolumbar fracture. However, associated disadvantages include severe trauma, extensive bleeding, long rehabilitation time, and long postoperative duration of intractable lumbar stiffness and low back pain. Percutaneous pedicle screw external fixation can reduce injury caused by screw insertion into the paraspinal muscles; particularly in acute thoracolumbar vertebral compression fracture with simple anterior spinal column injury. We hypothesized that minimally invasive posterior percutaneous pedicle screw fixation for acute thoracolumbar vertebral fractures with simple anterior spinal column injury would exhibit good curative effects. OBJECTIVE： To retrospectively analyze the curative effects of minimally invasive posterior percutaneous pedicle screw fixation on acute thoracolumbar vertebral fractures with simple anterior spinal column injury. METHODS： This retrospective, single-center, self-controlled trial was performed in PLA 153 Central Hospital, Zhengzhou, Henan Province, China. Thirty-two patients with acute thoracolumbar vertebral fracture with simple anterior spinal column injury（22 males and 10 females, average age 34.7 years, range 25-47 years） were included. All patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation and were followed up for 3 months. The primary outcome measure was the Cobb angle of the injured vertebral body before, immediately after, and 3 months after internal fixation, which was used to investigate the change in the thoracolumbar spine curvature. The secondary outcome measures included： the anterior height of the injured vertebral body and radiographic findings before and immediately after internal fixation and at the last follow-up（to evaluate the recovery of thoracolumbar vertebral fracture）, operation time, intraoperative blood loss, duration of hospitalization, and incidence of adverse events 3 months after internal fixation. The study protocol had been ap

关 键 词：组织工程 外科手术 微创性 脊柱骨折 骨科植入物 脊柱植入物 临床试验 胸腰椎骨折 微创 椎弓根螺钉 前中柱损伤 COBB角 X射线 不良反应 自身对照试验 

分 类 号：R318[医药卫生—生物医学工程]