NCT02896998已完成不适用
Routine Versus on Demand Removal of the Syndesmotic Screw
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2017年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Functional outcome through the Olerud-Moland score
研究概览
简要总结
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 17 years of age
- •Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
- •Syndesmotic screw placed within two weeks of the trauma
- •Being in such condition that one is able to possibly undergo a second procedure
排除标准
- •ISS score >15
- •Injuries to the ipsi- and contralateral side which might hamper rehabilitation
- •Other medical conditions which hamper physical rehabilitation
- •Incomprehensive understanding of the Dutch language
结局指标
主要结局
Functional outcome through the Olerud-Moland score
时间窗: 1 year following initial treatment
次要结局
- Functional outcome through the OAFAS(1 year following initial treatment)
- Pain through the Visual Analog scale(1 year following initial treatment)
- Range of motion(1 year following initial treatment)
- Surgical complications(1 year following initial treatment)
- Quality of Life through the EQ-5D-5L(1 year following initial treatment)
- Health care consumption through the iMCQ(1 year following initial treatment)
- Loss of productivity through the iPCQ(1 year following initial treatment)
研究者
J.C. Goslings
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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