NCT00205998终止4 期
Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)
AO Clinical Investigation and Publishing Documentation6 个研究点 分布在 3 个国家目标入组 450 人开始时间: 2001年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- - Document specific indications for the surgical treatment of distal radius fractures using the LCP
研究概览
简要总结
Primary objective of the study is to demonstrate specific indications for the
surgical treatment of distal radius fractures using the locking compression
plate.
详细描述
In addition the differences between the surgical treatment compared to
conservative treatment with respect to fracture healing, functional outcome
and subject satisfaction will be analysed after 6w./6m./1y./2y.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature female and male
- •Distal radius and ulnar fractures AO 23
- •10 days after injury
排除标准
- •general or local conditions adversely affecting the bone physiology
- •osteosynthesis close to the wrist joint where a different implant has been used
- •history of drug and alcohol abuse
结局指标
主要结局
- Document specific indications for the surgical treatment of distal radius fractures using the LCP
次要结局
- - Primary reduction and maintenance of reduction of the plate fixation
- - Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
- - Patient and surgeon satisfaction
- - Analysis of the occured complications
研究者
研究点 (6)
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