NCT03238521已完成不适用
Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年11月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Dose area product in cGy.cm2 (DAP)
研究概览
简要总结
To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18 and 80 years-old;
- •Patient with an indication of PPTLO for one or two segments
- •Patient in a position to understand protocol information;
- •Patient who received information about the protocol and who did not show opposition to participate
排除标准
- •History of posterior spinal fusion surgery on the spinal level concerned by the study;
- •Morbid obesity (body mass index greater than 35 kg / m²);
- •Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
- •Simultaneous participation in another research protocol involving the human person
研究组 & 干预措施
classical pedicle finder
Active Comparator
Spinal osteosynthesis with classical pedicle finder
干预措施: Spinal osteosynthesis with classical pedicle finder (Procedure)
pedicle finder with impedancemetry
Experimental
Spinal osteosynthesis with pedicle finder with impedancemetry
干预措施: Spinal osteosynthesis with pedicle finder with impedancemetry (Procedure)
结局指标
主要结局
Dose area product in cGy.cm2 (DAP)
时间窗: Surgery Day
Dose area product in cGy.cm2 (DAP)
次要结局
- Operating time in minutes.(Surgery Day)
- Radiation duration in seconds (measured on the fluoroscope);(Surgery Day)
- Radiation rate(Surgery Day)
- Path of pedicle screws extracted from fluoroscopic images(Day 2 after surgery)
研究者
研究点 (2)
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