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临床试验/NCT01979198
NCT01979198已完成不适用

Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Analysis of Discs and Vertebral Body Height at Fractured and Adjacent Levels

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Radiologic outcomes

研究概览

简要总结

The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
  • incomplete neurological deficit with a canal compromise less than 50%;
  • complete neurological deficit;
  • multilevel spinal injury or multiple trauma.

排除标准

  • progression of the neurological deficit;
  • a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.

结局指标

主要结局

Radiologic outcomes

时间窗: up to postoperative 161 months

* Injured vertebral body height * Kyphotic angle * Regional segmental motion

次要结局

  • Functional outcomes(up to postoperative 161 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Chief, Division of Spine Surgery, Dep. of Orthopedics and Traumatology

Taipei Veterans General Hospital, Taiwan

研究点 (1)

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