Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails
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 between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.
详细描述
Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.
The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 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
- •Stable both-bone forearm fracture
- •Age < 16 years old
- •Dislocation
排除标准
- •Fracture older than 1 week
- •No informed consent
- •Refracture
- •Open fracture (Gustillo 2 and 3)
结局指标
主要结局
pronation and supination
次要结局
- complications, function, esthetics, complaints in daily living, X-rays