Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- secondary displacement of the fracture
研究概览
简要总结
The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.
详细描述
Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.
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
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •open growth Zone
- •displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
- •written informed consent
排除标准
- •intraarticular fractures
- •open fractures
- •unstable fractures
研究组 & 干预措施
upper arm combi cast
standardized treatment
干预措施: combi cast (Device)
forearm combi cast
Treatment with a forearm combi cast should be a sufficient immobilization
干预措施: combi cast (Device)
结局指标
主要结局
secondary displacement of the fracture
时间窗: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
radiological evaluation
次要结局
- Mobilisation of elbow joint after cast removal(4 weeks and 7 weeks after closed reduction of fracture)
- Wearing comfort of the two different casts(5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture)
研究者
Georg Staubli
Dr. med.
University Children's Hospital, Zurich