Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 11
- 主要终点
- Compare the management and clinical methods
研究概览
简要总结
The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.
详细描述
Multicenter prospective cohort observational study. The enrollment period will be 5 years. An additional 4 months will be required to allow the last enrolled patients to complete the 120-day follow-up. It is estimated to enroll a total of 7,000 patients. To facilitate the participation in the study of non-university or IRCCS assistance departments, two methods of data collection will be possible:
- High intensity: continuous data collection for the whole period of the study on all the incident cases
- Low intensity: data collection once a year on incident cases over a continuous period of 1 month, with a reduced number of variables.
The choice of the level of intensity with regard to the data collection method will take place on a voluntary basis (each OU will actually choose the type of speed with which it intends to collaborate in the project, after communicating to the steering committee and to the biostatisticians of the study)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture of the femur, regardless of the cause
- •Age ≥ 65 years
- •Willingness to participate in the study by the patient or a relative / caregiver, if the patient is unable to understand and is not "competent" at the time of the evaluation.
- •Able to speak the Italian language
排除标准
- 未提供
结局指标
主要结局
Compare the management and clinical methods
时间窗: Entire study duration, approximately 5 years
Compare the management and clinical methods of the various centers and evaluate the relationship between indicators of treatment adherence to international guidelines and the short and long-term outcomes of patients.
次要结局
- Improvement of clinical practice(Entire study duration, approximately 5 years)
- Enhance the model of orthogeriatrics and geriatric-orthopedic management(Entire study duration, approximately 5 years)
- Improvement of collaboration of specialists from various disciplines(Entire study duration, approximately 5 years)
- Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group(Entire study duration, approximately 5 years)
- Increase the sensitivity of doctors and operators on the problems of the elderly population with hip fracture between participating centers(Entire study duration, approximately 5 years)