NCT00626470已完成不适用
A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate
St. Olavs Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fracture movement postoperatively
研究概览
简要总结
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
- •(can include; Patients with cognitive problems (ie. dementia etc)
排除标准
- •Patients with pathological fractures
- •Multitrauma patients
- •Patients not able to walk before the fracture
- •Under 19 years old.
- •Patients with fractures needing other treatments than gliding hip screws
- •Reverse oblique fractures.
研究组 & 干预措施
-TSP
Active Comparator
Patients operated without TSP
干预措施: Addition of TSP to DHS (Procedure)
+TSP
Active Comparator
Patients operated with TSP
干预措施: Addition of TSP to DHS (Procedure)
结局指标
主要结局
Fracture movement postoperatively
时间窗: One year
次要结局
- Reoperation(One year)
- Pain postoperatively(one year)
- complications postoperatively(one year)
- Hip function postoperatively(one year)
- Fracture healing(one year)
研究者
研究点 (2)
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