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临床试验/NCT01293916
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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2006年6月最近更新:
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
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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