跳至主要内容
临床试验/NCT00888550
NCT00888550已完成不适用

A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Denver Health and Hospital Authority1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年8月1日最近更新:
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
20
试验地点
1
主要终点
Differences across time and between groups for pain and range of motion

研究概览

简要总结

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.

The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

排除标准

  • •Pregnant Women
  • •Prisoners

研究组 & 干预措施

2. No Splinting

Active Comparator

干预措施: No Splinting (Procedure)

1. Splinting

Experimental

干预措施: Post-Op Splinting (Procedure)

结局指标

主要结局

Differences across time and between groups for pain and range of motion

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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