NCT01293916已完成不适用
Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts
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
- 52
- 试验地点
- 2
- 主要终点
- Acceptable fracture healing
研究概览
简要总结
Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.
详细描述
Introduction
- double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old.
- Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment.
Methods
- Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures
- patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained
- Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation
- After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.
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 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diaphyseal femur fracture
- •age between 2 and 6 years old
排除标准
- •underlying bone disorder
- •neuromuscular disease
研究组 & 干预措施
Double leg spica cast
Active Comparator
The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
干预措施: Spica casting (Other)
Single leg spica casts
Experimental
The study group is the single leg spica cast group
干预措施: Spica casting (Other)
结局指标
主要结局
Acceptable fracture healing
时间窗: 8 weeks
evaluation of shortening, angulation, and rotation radiographically at time of fracture healing
次要结局
未报告次要终点
研究者
研究点 (2)
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