NL-OMON34752已完成不适用
Displaced midshaft fractures of the clavicle: non-operative treatment versus Acumed ® plate fixation. A multi-centre randomised controlled trial in the Netherlands. - Non-operative treatment vs. locking plate for midshaft clavicle fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Completely displaced midshaft fracture of clavicle (Robinson class 2B1 or 2B2)
- •Age between 16 and 60 years
- •No medical contra indications to general anaesthesia
- •Signed informed consent
排除标准
- •Age less than 16 years or older than 60 years
- •A fracture in the proximal or distal third of the clavicle
- •A pathologic fracture (bony abnormalities at the side of the fracture)
- •An open fracture
- •Neurovascular injury with objective neurological findings on physical examination
- •An associated head injury (Glasgow Coma Scale <12)
- •An upper extremity fracture distal to the shoulder
- •A fracture seen more than 14 days after injury
- •Inability to give informed consent with the randomisation procedure
- •A medical contra-indication to surgery/ anaesthesia (such as a heart disease, kidney failure or active chemotherapy)
- •Inability to comply with follow-up
- •Prior surgery to the shoulder
- •Prior shoulder complaints
研究者
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