NCT00703716已完成不适用
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
Integra LifeSciences Services10 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2008年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 10
- 主要终点
- The consolidation rate
研究概览
简要总结
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX
详细描述
Hip fractures are a serious public health problem. The current incidence is projected to increase fourfold worldwide by the year 2050. This affliction is obviously linked to the aging of the population and the absence of a systematic prevention of osteoporosis.
This leads to the creation of a minimally invasive, or ever percutaneous, implantable osteosynthesis material which associates :
- the well-known reliability of osteosynthesis using screw-plate with barrel,
- the safety of the fixation with Surfix concept, locking the screws to the plate using lock-screws,
- a modularity thanks to the choice between 3 sizes of barrel,
- the creation of a simple material, easing the operative surgery by minimally invasive approach.
The TRAUMAX answers to all those characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Man or woman
- •Age > 18
- •with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
排除标准
- •Patient with an acute infection
- •Patient with a major osseous deterioration which not allows a correct support of the screws in the bone
- •Patient with an ASA score of 4 or 5
- •Patient whom the time between the fracture and the surgery could be higher than 8 days
结局指标
主要结局
The consolidation rate
时间窗: 6 months after surgery
The rate of complication due to the device
时间窗: 6 months after surgery
次要结局
- operating time(during the surgery)
- PMA score(3 and 6 months after surgery)
- The duration of the use of the amplifier of brilliancy during the intervention(during the surgery)
- The radiological position of the device(5 days, 3 and 6 months)
- The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.(3 and 6 months after surgery)
研究者
研究点 (10)
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