跳至主要内容
临床试验/NCT00314600
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

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

发起方
Colaris, Joost, M.D.
申办方类型
Indiv

研究点 (4)

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