跳至主要内容
临床试验/NCT05244317
NCT05244317撤回不适用

Removable Splint Versus Cast in the Treatment of Distal Radius Fracture in Children of Refugees' Camps: a Randomized Controlled Trial

University of Duhok2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
146
试验地点
2
主要终点
complication

研究概览

简要总结

Refugees live in camps under unusual living conditions. The children in the camps may not have enough safe facilities to play. If an injury occurred in these children, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.

详细描述

Fractures of the distal forearm (especially radius) are the most common fracture reported in childhood and a frequent reason for visiting the emergency unit and orthopedic clinic in hospitals. Because of the age of patients and proximity to the joint, these fractures heal well and have a good ability to remodel the bone even with mild displacement. Therefore, most of these fractures are treated conservatively by a short arm cast with frequent visits to the orthopedic clinic within 4-6 weeks without significant complications. Several studies report successful treatment of these fractures by removable splint as a substitute for the cast. The splints proved to be safe and cost-effective in managing these common minor injuries in children under usual living conditions.

Refugees live in camps under unusual living conditions. The children in these camps may not have enough safe facilities to play. If they got an injury, the classical and adequate regime of treatment may not be available. Hence, it may be valuable to find simple, cheap, and safe methods of treatment for their injuries.

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
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: between 2-12 years old age.
  • Sex: both male and female.
  • Address: living in one of the refugees' camps in the Duhok Government.
  • Duration of symptoms: less than 7 days.
  • Type of injury: fracture at the distal end of radius proofed by a radiograph film in two views (posteroanterior and lateral).
  • Type of fracture: it may be any of the followings:
  • torus (buckle) fracture,
  • undisplaced or minimally displaced fracture distal radius physis (type 1 and 2 only) that do not need reduction.
  • undisplaced or minimal displaced metaphyseal fracture that does not need reduction. Note: The minimally displaced fracture will be considered when the fracture fragments have a tilt of fewer than 15 degrees and shift less than 5 millimeters at the fracture site in both views.

排除标准

  • open fractures
  • pathological fractures
  • displaced fractures that need reduction
  • delayed presentation beyond 7 days
  • associated fracture of the ulnar bone
  • polytraumatic cases.

结局指标

主要结局

complication

时间窗: up to 12 weeks.

proportion of complication occurrence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jagar Omar Doski

Assistant Professor of Orthopedics

University of Duhok

研究点 (2)

Loading locations...

相似试验

Removable Splint Versus Cast in the Treatment of... | 临床试验