Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Peritrochanteric Fragility Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Implant failure
研究概览
简要总结
The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.
The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.
Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.
详细描述
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.
The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.
Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.
Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.
This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low Energy Mechanism
- •Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
排除标准
- •A fracture due to malignancy
- •Previous contralateral fracture
- •Inability to walk before the fracture
- •An inability to comply with rehabilitation
- •Follow-up of less than 6 months
结局指标
主要结局
Implant failure
时间窗: 6 months
Rate of cut out , cut through.
次要结局
- Complications(3 weeks, 3 months , 6 months)
- Offset(6 months)