INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)
- Conditions
- Fractures or Dislocations
- Registration Number
- NCT02150980
- Lead Sponsor
- McMaster University
- Brief Summary
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
Number of Participants:
40,000
Primary Research Objectives:
To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):
1. 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.
2. 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) and admission to hospital time (e.g. \<72 hours or \> 72 hours).
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 a composite of mortality, mortality, re-operation and infection within 30 days from hospital admission for all research objectives.
Duration of Patient Follow-Up:
Study participants will be followed until 30 days post hospital admission.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39797
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality, re-operation and infection 30 days post-hospital admission
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Clínica Zabala
🇦🇷Buenos Aires, Argentina
Princess Marina Hospital
🇧🇼Gaborone, Botswana
Hospital de Beneficencia Sirio-Libanes
🇧🇷San Paolo, Brazil
Hospital de Clínicas - UNICAMP
🇧🇷São José dos Campos, Brazil
Baptist Hospital Mutengene
🇨🇲Mutengene, Cameroon
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital
🇨🇳Beijing, Beijing, China
Xiamen University affiliated First Hospital
🇨🇳Xiamen, Fujian, China
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