跳至主要内容
临床试验/NCT01851031
NCT01851031已完成不适用

A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach

West China College of Stomatology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月1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
60
试验地点
1
主要终点
the number of participants with facial nerve injury

研究概览

简要总结

The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.

详细描述

Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.

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
5 Years 至 56 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (1)clinical and imaging diagnosis of medial or low condylar fractures
  • (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
  • (3)no previous surgical treatment

排除标准

  • (1)medial or low condylar fractures without obvious displacement
  • (2)patients who had previously undergone unsuccessful surgery
  • (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision

结局指标

主要结局

the number of participants with facial nerve injury

时间窗: from 3 months to 1 year after surgery

to explore whether the minor parotid anterior approach could prevent facial nerve injury.

次要结局

未报告次要终点

研究者

发起方
West China College of Stomatology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hou Jia

Principal Investigator

West China College of Stomatology

研究点 (1)

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