Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Rate of fracture displacement
研究概览
简要总结
The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.
详细描述
The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions
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
- •Salter Harris I or II fracture of the distal radius or a forearm fracture
- •informed consent
排除标准
- •open/instable/intraarticular fracture
- •age <4 years or > 16years
- •no informed consent
结局指标
主要结局
Rate of fracture displacement
时间窗: in the first four weeks after trauma
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)
次要结局
未报告次要终点