经皮微创手术与开放手术治疗胸腰椎骨折的多中心随机对照试验：研究方案。
Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.
机构信息
Faculty of Medicine, University of Sao Paulo, Ribeirao Preto, Brazil.
Department of Medical Clinic, Faculty of Medicine, University of Campinas, Campinas, Brazil.
出版信息
BMC Musculoskelet Disord. 2019 Aug 31;20(1):397. doi: 10.1186/s12891-019-2763-1.
BACKGROUND
Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems.
METHODS/DESIGNS: This study is designed as a multi-center, randomized controlled trial of patients aged 18-65 years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5 l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24 months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT).
DISCUSSION
Surgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24 months of follow-up.
TRIAL REGISTRATION
ClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.
背景
胸腰椎骨折最常发生于脊柱，不稳定骨折需手术治疗。经皮微创技术的引入减少了开放后路手术相关的疼痛，并通过避免对椎旁肌肉的损伤和剥离，降低了手术的发病率。本研究的目的是比较经皮微创入路与传统开放入路治疗胸腰椎骨折的手术治疗效果，两种方法均使用类似的椎弓根脊柱固定系统。
方法/设计：本研究为多中心、随机对照试验，纳入年龄 18-65 岁、计划行后路固定手术的患者。将随机分配采用传统开放入路或经皮微创入路治疗。主要结局指标是术后疼痛，采用视觉模拟评分（VAS）进行测量。次要结局参数包括术中出血量、术后引流量、手术时间、住院时间、SF-36、EQ-5D-5l、HADS、止痛药物使用、术后下地活动时间、术中透视时间、椎体后凸角、骨折椎体高度、椎管压缩、椎弓根螺钉准确性、植入物断裂或松动。患者将在术后 1、2、3、6、12 和 24 个月进行随访，并通过临床和影像学检查、平片和计算机断层扫描（CT）评估结果。
讨论
本研究将通过多中心随机研究比较开放或经皮微创入路治疗胸腰椎骨折，两种方法均采用类似的固定系统，并根据术后 1、2、3、6、12 和 24 个月的临床和影像学参数进行评估。
试验注册
ClinicalTrial.gov 注册号：1.933.631，代码：NCT03316703，于 2017 年 5 月批准。
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