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临床试验/NCT03810092
NCT03810092已完成不适用

Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Centre Hospitalier Departemental Vendee5 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2019年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
5
主要终点
Hemoglobin Rate

研究概览

简要总结

Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

研究设计

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

入排标准

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

入选标准

  • Age ≥ 75 years
  • Patient operated on a fracture of the upper extremity of the femur
  • Patient, family or close relative who does not object to participation in the study
  • Patient affiliated to a social security system
  • Patient who can be monitored as part of the protocol

排除标准

  • Refusal to participate in the study (patient, family or trusted relative)
  • Patient with support on the operated limb not authorized by the surgeon
  • Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
  • Patient with a pathologic fracture
  • Patient included in Category 1 interventional research (involving a drug or medical device)
  • Patient deprived of liberty
  • Patient not affiliated to a social security system

结局指标

主要结局

Hemoglobin Rate

时间窗: 5 days after surgery

Questionnaire Activities of Daily Living

时间窗: Pre-fractural and 6 months after surgery

For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points. A loss of autonomy will be defined by the decrease of one or more points in the ADL. Result showed here is the difference of ADL score intra patient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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