Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Days to Ambulation
研究概览
简要总结
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing & bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.
排除标准
- •• Children with clinical suspicion but lack of radiographic evidence for toddler's fracture
- •Fractures displaced >2mm
- •Open fractures
- •Pathologic fracture
- •Fractures involving the physis
- •Previous fracture of the ipsilateral extremity
- •Concomitant fracture involving the ipsilateral or contralateral leg
- •Concomitant head injury
- •Non-ambulatory children (i.e., those who have not yet begun to walk)
- •Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)
- •Children who are geographically prohibited from following up in our system
- •Children whose caregivers are not proficient in English
- •Presentation >7 days from injury
- •Cases considered to be non-accidental trauma
结局指标
主要结局
Days to Ambulation
时间窗: 12 weeks
Recorded in parent journal, date of first ambulation without assistance.
次要结局
- Fracture displacement(12 weeks)