NCT00989222已完成不适用
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study
Danderyd Hospital2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- PRWE (patient rated wrist evaluation) score
研究概览
简要总结
Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
- •Patient aged 20-70 years with no previous fracture of either wrist.
排除标准
- •Bilateral fractures,
- •Other current injury to the upper extremities,
- •Dementia, OR
- •Severe comminution or too small distal fragment to allow plating.
结局指标
主要结局
PRWE (patient rated wrist evaluation) score
时间窗: 3,6 and 12 months
次要结局
- Objective function (range of movement and grip strength)(3,6 and 12 months)
研究者
研究点 (2)
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