NCT00397852Unknown不适用
Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires
Colaris, Joost, M.D.3 个研究点 分布在 1 个国家目标入组 110 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
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- re-operations/ re-dislocations
研究概览
简要总结
We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.
详细描述
children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.
After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.
Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: the number of re-dislocations, re-operations, consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both-bone forearm fracture
- •dislocated
- •stable after reposition
- •age < 16 years
排除标准
- •fracture older than 1 week
- •no informed consent
- •refracture
- •open fracture (Gustillo 2 and 3)
- •both fractures of type torus
结局指标
主要结局
re-operations/ re-dislocations
次要结局
- pronation and supination
- complications, function, esthetics, complains in daily living, X-rays
研究者
研究点 (3)
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