NCT00205959已完成4 期
Comparison of Standard Treatment Methods for Proximal Humerus Fractures
AO Clinical Investigation and Publishing Documentation2 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2002年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Functional outcome based on "constant and neer score" after 12 months
研究概览
简要总结
The aim of the study is to compare the results regarding fracture healing
and functional outcome after the treatment of proximal humeral fractures
with the four different treatment methods after 12w./6months and 12 months
based on radiological evaluation as well as the "constant score" and the
"neer score".
详细描述
Evaluation of proximal humeral fractures using a new stable-angled implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •fractures of proximal humerus
- •age over 18 years
- •completed skeletal development
- •fracture less than 5 days old
排除标准
- •open fractures
- •pseudoarthrosis, pathological or refractures
- •ipsilateral fractures of distal humerus or elbow
- •polytraumatic conditions
- •pregnancy
- •subject with known history of diseases that influence the healing process
- •alcohol, drug abuse
结局指标
主要结局
Functional outcome based on "constant and neer score" after 12 months
Radiological comparison of the fracture healing
次要结局
- Analysis of occured complications
- Subjective patient judgement of before and after treatment according to DASH-questionnaire
- Radiological evaluation of possible misallocation
研究者
研究点 (2)
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