Feng Zhenhua, Li Xiaobin, Tang Qian, Wang Chenggui, Zheng Wenhao, Zhang Hui, Wu Ai-Min, Tian Naifeng, Wu Yaosen, Ni Wenfei
Department of Spine Surgery, Orthopaedic Hospital, The Second Affiliated Hospital and Yuying Children's Hospital of the Wenzhou Medical University, The Second Medical School of the Wenzhou Medical University, Zhejiang Spine Center, Wenzhou, China.
BMJ Open. 2017 Oct 22;7(10):e017227. doi: 10.1136/bmjopen-2017-017227.
Transforaminal lumbar interbody fusion (TLIF) has been widely used in the treatment of lumbar degenerative disc disorders and shows favourable clinical results. Recently, cortical bone trajectory (CBT) has become a new trajectory for screw insertion in the lumbar spine. Several biomechanical studies have demonstrated that the CBT technique achieves screw purchase and strength greater than the traditional method. Currently, the available data on the clinical effectiveness of the two performed surgeries, TLIF with CBT screws (CBT-TLIF) and TLIF with traditional pedicle screws (PS-TLIF), are insufficient. This is the first randomised study to compare CBT-TLIF against traditional PS fixation and will provide recommendations for treating patients with lumbar degenerative disc disorders.
A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of 254 participants with lumbar disc degenerative disease who are candidates for TLIF surgery will be randomly allocated to either the CBT-TLIF group or the PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are the incidence of adjacent cranial facet joint violation, fusion rate and the screw loosening rate. Secondary clinical outcome measures are Visual Analogue Scale (VAS) of back pain, VAS of leg pain, Oswestry Disability Index, operative time, intraoperative blood loss and complications. These parameters will be evaluated on day 3, and then at 1, 3, 6, 12 and 24 months postoperatively.
This study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (batch: 2017-03). The results will be presented in peer-reviewed journals and an international spine-related meeting after completion of the study.
NCT03105167; Pre-results.
经椎间孔腰椎椎体间融合术（TLIF）已广泛应用于腰椎间盘退变疾病的治疗，并显示出良好的临床效果。近年来，皮质骨轨迹（CBT）已成为腰椎螺钉置入的新轨迹。多项生物力学研究表明，CBT技术获得的螺钉把持力和强度优于传统方法。目前，关于两种手术（使用CBT螺钉的TLIF，即CBT-TLIF和使用传统椎弓根螺钉的TLIF，即PS-TLIF）临床疗效的现有数据不足。这是第一项比较CBT-TLIF与传统PS固定的随机研究，将为腰椎间盘退变疾病患者的治疗提供建议。
将进行一项双盲随机对照试验（对患者和统计人员设盲，而非对临床医生和研究人员设盲）。共有254例适合TLIF手术的腰椎间盘退变疾病患者将按1:1的比例随机分配至CBT-TLIF组或PS-TLIF组。主要临床结局指标为相邻上位小关节侵犯的发生率、融合率和螺钉松动率。次要临床结局指标为背痛视觉模拟评分（VAS）、腿痛VAS、Oswestry功能障碍指数、手术时间、术中出血量及并发症。这些参数将在术后第3天进行评估，然后在术后1、3、6、12和24个月进行评估。
本研究已通过温州医科大学附属第二医院育英儿童医院伦理委员会审查并批准（批号：2017-03）。研究完成后，结果将在同行评审期刊和国际脊柱相关会议上发表。
NCT03105167；预结果。
