NCT00642265已完成不适用
The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
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
- 100
- 试验地点
- 6
- 主要终点
- Union
研究概览
简要总结
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.
Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.
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
- Double (Participant, Investigator)
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
- •18 to 65 year
- •100% displaced midshaft clavicular fracture
- •shortening
- •male: 18mm
- •female: 14mm
排除标准
- •pregnancy
- •pathological fracture
- •open fracture
- •history of frozen shoulder
- •ipsilateral fracture of shoulder or scapula
- •neurovascular injury
- •contraindication to anaesthesia
研究组 & 干预措施
2
Active Comparator
conservative treatment
干预措施: sling (Other)
1
Experimental
operative treatment
干预措施: osteosynthesis (Procedure)
结局指标
主要结局
Union
时间窗: 1 year
Functionality
时间窗: 1 year
次要结局
- Complications(1 year)
- Cost(1 year)
- Relation with medication(1 year)
- Relation with job(1 year)
- Time to heal(1 year)
- Relation with smoking(1 year)
研究者
研究点 (6)
Loading locations...
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