跳至主要内容
临床试验/NCT03928912
NCT03928912已完成不适用

Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model: A Case-Control Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2019年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
234
试验地点
1
主要终点
the Gustilo type of the open fracture

研究概览

简要总结

Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. This study aimed to confirm the risk factors of nonunion of tibial shaft fracture. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

详细描述

Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. The investigators retrospectively analyzed the demographics of these participants in our hospital that occur long tubular fracture. One group is participants that existed fracture nonunion. And the other group is the participants that did not exist fracture nonunion. The investigators recorded twelve variables and confirm the risk factors by uni-variate Logistic regression analysis. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The tibial shaft fracture was caused by trauma.

排除标准

  • The tibial shaft fracture was caused by tumor, infection and other reasons.

结局指标

主要结局

the Gustilo type of the open fracture

时间窗: the outcome of the Gustilo type can acquire within 1 week.

the Gustilo type of the open fracture can be divided into three types. And the type I is the open fractures with wounds that is clean and smaller than 1cm. Type II is the the open fractures with wounds that is moderately unclean and bigger than 1cm, which also has a wide soft tissue injury. Type III is the all open fractures that accompany with severe soft tissue injury and pollution.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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