NCT00609479已完成不适用
Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a 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
- 60
- 试验地点
- 3
- 主要终点
- DASH-questionnaire
研究概览
简要总结
The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.
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
- •Fracture Older type
- •Fracture Older type 3.
排除标准
- •Fractures older than 3 weeks.
- •Pregnancy.
- •Seq. after previous fracture.
- •Distal fragments volar cortex < 10 mm.
- •Open fracture larger than Gustillo
- •Disability due to other illness.
- •Congenital abnormity or injury/disease in the affected extremity.
- •Not capable of mentally/physically to cooperate.
- •Not able to go to followup on the operating hospital.
研究组 & 干预措施
1
Experimental
Internal fixation with Micronail. 41 patients.
干预措施: Osteosynthesis (Procedure)
2
Experimental
External fixation with Hoffmann-II-non-bridging. 41 patients.
干预措施: Osteosynthesis (Procedure)
结局指标
主要结局
DASH-questionnaire
时间窗: 3 months
次要结局
- PRWE-questionnaire(3 months)
研究者
研究点 (3)
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