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临床试验/NCT04062604
NCT04062604Unknown不适用

The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
350
试验地点
1
主要终点
Objective assessment of the lower limb function

研究概览

简要总结

The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

详细描述

All four questionnaires (LLTQ, LEFS LLFI-10 and LLFI) will be translated and adopted to the Polish conditions. The detailed medical/ epidemiological history will be collected in each patient. The fracture will be assessed based on the x-ray examination and will be qualified according to AO classification. NRS (Numerical Rating Scale) will be used to assess the pain intensity. SF36, QoL, CSQ, COPE and HADS questionnaire will be used to evaluate patient's the quality of life (subjective assessment). First assessment will be done before operation and then after 3, 6, 12, 24 month postoperation treatment.

With this main study, there is a plan to assess not only femur fractures patients, but the investigators would like to have addtional groups of the patients with hip and knee allopasty and knee arthroscopy with slightly different follow-up period: before the oparation, 1 and 12 month after the treatment.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Signed Patient Informed Consent
  • •Patients planned for the surgical treatment

排除标准

  • 未提供

结局指标

主要结局

Objective assessment of the lower limb function

时间窗: 12 month

Physical exam

Subjective assessment of the lower limb function

时间窗: 12 month

Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome

次要结局

  • Subjective assessment of the lower limb function(3, 6, 24 months)
  • Objective assessment of the lower limb function(3, 6, 24 months)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcin Bednarek

Principal Investigator

Jagiellonian University

研究点 (1)

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