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临床试验/NCT01864785
NCT01864785Unknown不适用

Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Cobb angle

研究概览

简要总结

Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains controversial. Treatment varies from the conservative management to various types of surgery. Internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. In this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. To evaluate the result of the two kinds of treatment, the investigators design this clinical trial. So, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of thoracolumbar burst fracture

排除标准

  • smoking during the period of the trial
  • conservative treatment could be attempted
  • do not meet the requirements of follow-up

结局指标

主要结局

Cobb angle

时间窗: 18 months after surgery

Cobb angle is a variable for kyphotic deformity assessment

次要结局

  • failure of internal fixation(12 months after surgery)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhonghua Ling

resident

Jinling Hospital, China

研究点 (1)

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