A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Patient Radiation Exposure
研究概览
简要总结
This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.
详细描述
Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years old and above
- •Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion
排除标准
- •Prior ipsilateral tibial or femoral nail
- •Patients who cannot have interlocking screws placed
- •Pregnant women
结局指标
主要结局
Patient Radiation Exposure
时间窗: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)
Total Screw Placement Time
时间窗: During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)
time taken to place interlocking screws
Measurement of Screw Placement Angle
时间窗: Intraoperatively (at end of surgery)
Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Amount of Cumulative Radiation Exposure (in Grays)
时间窗: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Total radiation exposure during distal screw placement
次要结局
未报告次要终点
研究者
Carol A. Lin, MD
Assistant Professor
Cedars-Sinai Medical Center