INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39,797
- 试验地点
- 68
- 主要终点
- mortality, re-operation and infection
研究概览
简要总结
Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries.
Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.
详细描述
Number of Participants:
40,000
Primary Research Objectives:
To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):
- The incidence of major complications (mortality, re-operation and infection) as a composite outcome and the components of the composite within 30 days post-hospital admission.
- The factors (system and patient variables) associated with the composite of major complications (mortality, re-operation and infection) within 30 days post-hospital admission.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 years of age or older
- •admitted to a recruiting hospital for treatment of an orthopaedic injury
- •injury occurred within 3 months of hospital admission
- •patients diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.
排除标准
- 未提供
结局指标
主要结局
mortality, re-operation and infection
时间窗: 30 days post-hospital admission
次要结局
未报告次要终点
研究者
Mohit Bhandari
Professor of Surgery, Chair of Division of Orthopaedics
McMaster University