跳至主要内容
临床试验/NCT02856828
NCT02856828终止不适用

Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures

Duke University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • closed hip fracture requiring intramedullary nailing

排除标准

  • age <18 years

研究组 & 干预措施

Digital Image Enhancement (DIE) Group

Experimental

A novel digital image enhancement technology will be used intraoperatively

干预措施: DIE (Device)

Control Group

No Intervention

Standard intraoperative imaging will be used intraoperatively

结局指标

主要结局

Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge

时间窗: intraoperatively

Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge

时间窗: intraoperatively

Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge

时间窗: intraoperatively

次要结局

  • Image Quality and Reproducibility of Desired Images(intraoperatively)
  • Operative Time(intraoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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