跳至主要内容
临床试验/NCT01524718
NCT01524718Unknown不适用

Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Time of surgery

研究概览

简要总结

Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure.

The investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.

排除标准

  • 未提供

研究组 & 干预措施

Imaging with two X-ray image intensifiers

Experimental

There is no change in the procedure except for the imaging technique, while in the first group the X- ray image intensifier serves in the two planes, and being moved from one plane to the other, and in the second group the two devices are static in the same position, one in the AP plane and the other as the axial plane.

干预措施: Imaging with two X-ray image intensifiers (Radiation)

Imaging with one X-ray image intensifier.

No Intervention

The X- ray image intensifier serves in the two planes, and being moved from one plane to the other

结局指标

主要结局

Time of surgery

时间窗: 5 hours - operation time

time of operation

次要结局

  • Accuracy of reduction(5 hours - operation time)
  • X-ray time during surgery(5 hours - operation time)
  • Accuracy of nail position(5 hours - operation time)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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