钴合金椎弓根螺钉植入修复脊柱结核重度后凸畸形:自身对照临床试验方案  

Cobalt alloy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis: study protocol for a self-control trial

作　　者：侯煜[1] 杨雯[2] 杨帆[2] 卜宏建[1] 王林杰[1] 梁志兴[1] 孙博[1] 申志坤[1] 

机构地区：[1]河北大学附属医院,河北省保定市071000 [2]河北省保定市第三中心医院,河北省保定市071000

出　　处：《中国组织工程研究》2016年第44期6661-6666,共6页Chinese Journal of Tissue Engineering Research

摘　　要：背景:有研究表明,对脊柱结核重度后凸畸形采用前路或后路病灶内固定治疗均有良好疗效,但缺乏前瞻性、长期随访的病例对照研究的客观数据支持。目的:观察钴合金椎弓根螺钉植入修复脊柱结核重度后凸畸形的疗效及安全性。方法 /设计:研究为前瞻性、单中心、自身对照、开放性试验方案,在中国河北省保定市,河北大学附属医院完成。纳入试验的脊柱结核重度后凸畸形患者84例均进行钴合金椎弓根螺钉植入修复的诊断治疗标准,其中胸椎结核52例实施后入路28例,前入路24例,根据Frankel法分级:C级8例、D级31例和E级13例;腰椎结核32例实施后入路16例,前入路16例,根据Frankel法分级:C级7例、D级14例和E级11例。试验的主要观察指标为植入前、植入后2年脊柱胸段Cobb角,评价胸段侧弯的角度变化;次要观察指标为植入前、植入后2年患者X射线平片或者MRI检查,评估患者内固定治疗后的椎体融合情况,植入前、植入后2年患者Frankel分级结果评价植入后脊髓损伤神经功能恢复情况;其他观察指标为影响患者疗效相关因素的多元Logistic回归分析,植入后2年患者不良反应的发生率。试验经中国河北省保定市河北大学附属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。讨论:(1)此次试验试图证实钴合金椎弓根螺钉植入内固定修复脊柱结核重度后凸畸形有确切疗效;(2)同时分析前或后路入路哪种内固定入路方式更有利于治疗方法的选择;(3)为临床脊柱结核重度后凸畸形的内固定治疗提供长期随访的客观数据证据。BACKGROUND：There is evidence that internal fixation through an anterior or posterior approach for treatment of severe kyphotic deformity in spinal tuberculosis exhibits good curative effects. However, few prospective, long-term fol ow-up case control studies are reported. OBJECTIVE：To investigate the efficacy and safety of cobalt al oy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis. METHODS/DESIGN：This is a prospective, single-center, self-control, open-label trial, which wil be performed at the Affiliated Hospital of Hebei University, China. Eighty-four patients with severe kyphotic deformity in spinal tuberculosis wil be included according to the diagnosis criteria. Among 52 patients with tuberculosis of the thoracic spine, 28 wil undergo surgery through a posterior approach, and 24 through an anterior approach. According to the Frankel Grade classification, grade C, D and E spinal cord function wil be assessed in 8, 31 and 13 patients, respectively. Surgery through a posterior and anterior approach wil be respectively performed in half of 32 patients with tuberculosis of the lumbar spine. Grade C, D and E spinal cord function wil be assessed in 7, 14 and 11 patients, respectively. The primary outcome measure of this study wil be the Cobb angle at the thoracic spine segments before and 2 years after surgery, which wil be used to evaluate the angle of the spine curvature at the thoracic segments. The secondary outcome measures wil be X-ray scan or MRI findings before and 2 years after surgery, which wil be used to evaluate vertebral fusion after internal fixation;and Frankel Grade before and 2 years after surgery, which wil be used to evaluate recovery of spinal cord function after injury. Other outcome measures wil include multiple logistic regression analysis results of the factors that influence patient＆#39;s curative effects and the incidence of adverse events 2 years after surgery. The trial protocol has been approved by the Ethics Committee, Affiliated

关 键 词：组织工程 结核 脊柱 脊柱后凸 骨科植入物 脊柱植入物 临床试验 脊柱 脊柱结核 重度后凸畸形 X射线 MRI检查 COBB角 Frankel分级 多元LOGISTIC回归分析 影响因素 不良反应 自身对照试验 

分 类 号：R318[医药卫生—生物医学工程]