A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 12
- 主要终点
- Major Adverse Events related to treatment / residential status / immobilization
研究概览
简要总结
The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.
详细描述
Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study.
The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center.
As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed.
In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Geriatric patients with hip fractures Treated either with oOsteosynthesis or oEndoprosthesis
- •Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
- •Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent
- •Preoperative
排除标准
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Major Adverse Events related to treatment / residential status / immobilization
时间窗: From surgery up to 1 year follow-up
Major AEs related to treatment / residential status / immobilization: * Delirium * Congestive heart failure * Pneumonia * Deep venous thrombosis * Pulmonary embolism * Pressure ulcers * Myocardial infarction
次要结局
- Time from admission to surgery(Baseline (admission to surgery), about 1-2 days)
- Direct and indirect costs(Baseline up to 1 year follow-up)
- Time from admission to start of pain medication(Baseline (admission to surgery), about 1-2 days)
- Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization(From surgery up to 1 year follow-up)
- Timed up and go test (TUG)(12 weeks and 1 year follow-up)
- Parker Mobility Score(Baseline, 12 weeks and 1 year follow-up)
- Quality of Life(12 weeks and 1 year postoperative)
- Residential status(Baseline up to 1 year follow-up)
- Falls(From surgery up to 1 year follow-up)
- Number of patients receiving adequate secondary fracture prevention(Baseline up to 1 year follow-up)
- Number of patients for which the nutrition status was evaluated / adapted(Baseline (admission to discharge), about 1-2 days)
- Activities of daily living(Baseline, 12 weeks and 1 year postoperative)
- Number of re-admissions to an acute hospital(From surgery up to 1 year follow-up)
- Mortality(From surgery up to 1 year follow-up)
- Pain(From surgery up to1 year follow-up)
- Occurrence of a contralateral hip fracture(Retrospective assessment of pre-injury status up to 1 year follow-up)
- Time from admission to start of fluid management(Baseline (admission to surgery), about 1-2 days)
- Time from surgery to discharge 1 and 2(Baseline (admission to discharge), about 1-2 weeks)
- Medication(Baseline up to 1 year follow-up)