NCT00314600Unknown不适用
Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
Colaris, Joost, M.D.4 个研究点 分布在 1 个国家目标入组 60 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
- 60
- 试验地点
- 4
- 主要终点
- pronation and supination
研究概览
简要总结
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.
详细描述
Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.
Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints 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 midshaft forearm fracture
- •Age < 16 years old
排除标准
- •Dislocation
- •Fracture older than 1 week
- •No informed consent
- •Refracture
- •Open fracture (Gustillo 2 and 3)
- •Torus fractures of both ulna and radius
结局指标
主要结局
pronation and supination
次要结局
- complications, function, esthetics, complaints in daily living, X-rays
研究者
研究点 (4)
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