Femoral Antegrade Starting Tool (FAST): Clinical Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Procedure Time
研究概览
简要总结
This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).
详细描述
The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a femoral shaft fracture
- •Undergoing anterograde intramedullary nailing procedure
排除标准
- •Femoral head or neck fractures
结局指标
主要结局
Procedure Time
时间窗: 1 day
Time of the procedure from the initiation of the guidewire step (surgeon picking up the guidewire) to the removal of the FAST device following acceptable guidewire placement
次要结局
- Fluoroscopic Images(1 day)
- Number of guidewire drilling attempts(1 day)