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临床试验/NCT01464541
NCT01464541Unknown不适用

Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan

HaEmek Medical Center, Israel4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
4
主要终点
Patients with orbital fractures that require surgical repair will have their fracture"s" size measured intraoperatively by a ruler and/or a caliper in millimeters and compare it to the size measured by the CT scan.

研究概览

简要总结

Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture.

Hypothesis: there is difference between the CT measure fracture size and the actual intraoperative size.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • With orbital fracture (trauma) proved by CT scan and need operative repair.
  • Agree to participate.

排除标准

  • Patients that refuse to be included in the study.
  • Under the age of 18 years.
  • CT not performed or not available.
  • Not qualified to sign the consent form.

结局指标

主要结局

Patients with orbital fractures that require surgical repair will have their fracture"s" size measured intraoperatively by a ruler and/or a caliper in millimeters and compare it to the size measured by the CT scan.

时间窗: 2 years

Patients with orbital fractures that need to be operated. Their intraoperative fracture size will be measured by the orbital surgeon by a ruler or/and a caliper in millimeters. Size on CT scan is determined by counting the number of slides that show the fracture (for anteropsterior fracture we measure the number of coronal sections that show the fracture multiply X1-each section is 1millimeter thickness, and so on for mediolateral fractures we measure saggital sections number and for superoinferior fractures the axial sections that show the fracture.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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