The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
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
Marcin Bednarek
Principal Investigator
Jagiellonian University
