NCT02154620已完成不适用
Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Patient related wrist evaluation (PRWE)
研究概览
简要总结
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.
An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.
A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
- •Low energy injury
- •Patient 70 years old or older
- •72 hours or less since injury at time of diagnosis
- •Patient registered in the Stockholm region
- •Patient understands spoken and written swedish
排除标准
- •Intraarticular displacement in radiocarpal joint of more than 1 mm
- •Ulna fractured proximal to the base of the styloid process of ulna
- •Earlier unilateral functional impairment of hand/wrist
- •Injury to tendon, nerve or skin besides the fracture
- •Rheumatoid arthritis or other severe systemic joint disease
- •Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
- •Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
- •Medical illness that makes general anesthesia impossible
结局指标
主要结局
Patient related wrist evaluation (PRWE)
时间窗: 52 weeks
次要结局
- Patient related wrist evaluation (PRWE)(3 years)
研究者
Sari Ponzer
Professor
Karolinska Institutet
研究点 (2)
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