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临床试验/NCT03483844
NCT03483844已完成不适用

Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis

详细描述

CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition of the fixation points to avoid malposition of transpedicular screws and potential visceral, vascular or neurological damage.

It is known that multislice CT involves an increased radiation exposure for patients, while dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software.

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis who are candidated for vertebral arthrodesis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
5 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with progression of scoliosis without vertebral arthrodesis
  • patients able to maintain immobility for the duration of the exam
  • patients from 5 to 20 years old

排除标准

  • pregnancy
  • vertebral arthrodesis
  • patients unable to maintain immobility for the duration of the exam
  • non-compliant patients
  • obese patients
  • patients younger than 5 years old or older than 20 years old

结局指标

主要结局

Diagnostic accuracy

时间窗: Week 1 (post-surgery)

To evaluate the percentage of malpositioning of transpedicular screw. A percentage of malpositioning lower than 10% will be considered as acceptable.

次要结局

  • Radiation exposure(Baseline (pre-surgery) and week 1 (post-surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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