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临床试验/ISRCTN10328801
ISRCTN10328801已完成4 期

Evaluation of the safety and performance of the compression spinal fracture treatment system, TEKTONA® prospective study

Spineart (Switzerland)0 个研究点目标入组 37 人开始时间: 2023年6月14日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
37

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • 1. Aged 18 years or older
  • 2. Presenting one or more three stable vertebral fractures at non-adjacent levels, fractures type A1.1, A1.2, A1.3, A2 (gap between fragments less than 2 mm) and A3.1, A3.2, A3.3 according to Magerl classification
  • 3. Presenting vertebral traumatic fracture(s), due to high-energy trauma, or osteoporotic fall of one's own height
  • 4. Able to understand the investigation protocol, agree with the investigation plan, and complete the necessary documents
  • 5. Who voluntarily signed the informed consent form

排除标准

  • 1. Anterior treatment with cyphoplasty at the fractured level
  • 2. Unstable fractures of type B or C according to Magerl
  • 3. Size of the pedicules incompatible with safe access to the instrument

研究者

发起方
Spineart (Switzerland)

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