NCT04589598进行中(未招募)不适用
Comparison Between Femoral Neck System and Multiple Cannulated Screws in Non-displaced Femoral Neck Fracture
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.
详细描述
Clinical outcomes include reoperation, loss of fixation, and change of mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •18 years and older
- •non-displaced femoral neck fracture
- •community ambulator
排除标准
- •younger than 18 years
- •displaced femoral neck fracture
- •intertrochanteric fracture
- •subtrochanteric fracture
研究组 & 干预措施
FNS
Experimental
those who are treated with femoral neck system (FNS)
干预措施: Femoral Neck System (Device)
MCS
Active Comparator
those who are treated with multiple cannulated screw (MCS)
干预措施: Multiple Cannulated Screw (Device)
结局指标
主要结局
Reoperation
时间窗: 24 months
rate of reoperation
Reoperation
时间窗: 3 months
rate of reoperation
Reoperation
时间窗: 6 months
rate of reoperation
Reoperation
时间窗: 9 months
rate of reoperation
Reoperation
时间窗: 12 months
rate of reoperation
次要结局
- loss of fixation(24 months)
- loss of fixation(12 months)
- loss of fixation(3 months)
- loss of fixation(6 months)
- loss of fixation(9 months)
研究者
Young-Kyun Lee
Professor
Seoul National University Hospital
研究点 (1)
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