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临床试验/NCT00398268
NCT00398268Unknown不适用

Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study

Colaris, Joost, M.D.2 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
2
主要终点
pronation and supination

研究概览

简要总结

We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.

详细描述

children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.

After an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. 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, complains in daily living and complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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 forearm fracture
  • dislocated
  • unstable after reposition
  • age < 16 years

排除标准

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)
  • both fractures of type torus

结局指标

主要结局

pronation and supination

次要结局

  • complications, function, esthetics, complains in daily living, X-rays

研究者

发起方
Colaris, Joost, M.D.
申办方类型
Indiv

研究点 (2)

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