NCT00206011已完成4 期
Open Versus Endoscopic Surgery of Condylar Neck Fractures
AO Clinical Investigation and Publishing Documentation2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2003年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Functional outcome based on the Helkimo dysfunction index
研究概览
简要总结
This study is a comparison of open surgery versus an endoscopic approach in condylar neck fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.
详细描述
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient > 18 years
- •Unilateral or bilateral fracture of the condylar neck
- •Inclination of the condyle > 30%
- •Severe dislocation
- •Severe pain upon palpation/movement
- •Eligible for open reduction and internal fixation of the fracture
- •Amenable to endoscopic as well as open surgery
排除标准
- •High or intracapsular condylar neck fracture
- •Very low fractures that can be reduced intraorally
- •CMF malfunctioning
- •Drug or alcohol abuse
- •General or local conditions that adversely affect bone physiology
- •Physical or mental incapacity to sign informed consent
结局指标
主要结局
Functional outcome based on the Helkimo dysfunction index
时间窗: 3 months
次要结局
- Complication rate(24 months)
- Cost effectiveness(24 months)
研究者
研究点 (2)
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