Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
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
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
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
Donald Bae
Associate Professor of Orthopaedic Surgery
Boston Children's Hospital
