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临床试验/NCT02566018
NCT02566018已完成不适用

Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
personal dependency status

研究概览

简要总结

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

详细描述

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 65 years or above
  • Proximal humerus fracture
  • Informed consent by the patient or legal representatives to participate in the study

排除标准

  • More than one fracture, polytrauma
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Previous surgery of the proximal humerus on the same side
  • High energy trauma
  • Open Fracture
  • Insufficient German language skills

结局指标

主要结局

personal dependency status

时间窗: 6 months

A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.

次要结局

  • General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)(6 months)
  • Shoulder pain and disability index (SPADI)(6 months)
  • SSV(6 months)
  • Quality of life (utilities) derived using EQ-5D-5L(6 months)
  • range of motion(6 months)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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