INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 as individual components 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. Secondary Research Objective: To determine the rates of major complications within 30 days post-hospital admission by type of fracture treatment provided (e.g. splinting versus operative fixation). Diagnosis and Main Inclusion Criteria: This study has minimal exclusion criteria by design. All patients 18 years of age or older admitted to a recruiting hospital for treatment of an orthopaedic injury that occurred within 3 months will be eligible for participation. Patients who are diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included. Study Outcomes: The primary outcome is mortality within 30 days from hospital admission. The secondary outcomes are re-operation and infection within 30 days from hospital admission. Duration of Patient Follow-Up: Study participants will be followed until 30 days post hospital admission.

Official Title
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INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients

Conditions
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Fractures or Dislocations

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality, re-operation and infection |  | 30 days post-hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractures, outcomes of fracture care, burden of fractures, orthopaedic fractures, orthopaedic injuries, orthopaedic trauma, observational study, epidemiology