临床试验/NCT01190696

NCT01190696已完成2 期

Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children

Isfahan University of Medical Sciences1 个研究点分布在 1 个国家目标入组 46 人开始时间: 2009年2月最近更新: 2010年8月30日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Isfahan University of Medical Sciences
入组人数: 46
试验地点: 1
主要终点: Length of hospital stay

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

详细描述

There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 6 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•patients 6-12 years old with femoral shaft fracture without exclusion criteria

排除标准

•Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

结局指标

主要结局

Length of hospital stay

时间窗: at 1 months post-operatively

identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting

次要结局

the time to walking with aids(at 1 months post-operatively)
parent's satisfaction(at 1 months post-operatively)
the time absent from school(at 1 months post-operatively)

研究者

发起方

Isfahan University of Medical Sciences

申办方类型

Other

研究点 (1)

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