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临床试验/NCT00823823
NCT00823823已完成不适用

Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
Loss of Radius Fracture Reduction

研究概览

简要总结

It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.

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

  • •Displaced distal radius or mid-diaphyseal forearm fracture
  • •fracture requires closed reduction and cast immobilization
  • •Age 4-16 years
  • •Skeletally immature

排除标准

  • •Failed closed reduction
  • •Acute fracture > 1 week old
  • •Refracture injury
  • •Fracture requires surgical treatment
  • •Significant soft tissue swelling
  • •Associated neurovascular compromise
  • •Plastic deformation injuries

研究组 & 干预措施

Bivalved cast

Active Comparator

Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast

干预措施: Bivalved cast (Other)

Circumferential cast

Active Comparator

Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast

干预措施: Circumferential cast (Other)

结局指标

主要结局

Loss of Radius Fracture Reduction

时间窗: 4 weeks post-randomization

The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.

次要结局

  • Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations(Up to 4 weeks post-randomization)

研究者

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

Donald Bae

Associate Professor of Orthopaedic Surgery

Boston Children's Hospital

研究点 (1)

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