Brace Versus Casting in Pediatric Radial Head Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mayo score
研究概览
简要总结
Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month
详细描述
Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.
Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.
Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head
排除标准
- •The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
- •All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
- •Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
- •Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.
研究组 & 干预措施
Elbow cast
Device: Elbow cast
干预措施: elbow cast (Device)
Removable elbow brace
Device: Removable elbow brace
干预措施: Removable elbow brace (Device)
结局指标
主要结局
Mayo score
时间窗: 1 month
Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury
次要结局
- pain(1 month)
研究者
pengzhang
Department of orthopaedics and trauma
Peking University People's Hospital