INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS) (INORMUS)
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|ClinicalTrials.gov Identifier: NCT02150980|
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : February 25, 2019
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.
|Condition or disease|
|Fractures or Dislocations|
Number of Participants:
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||40000 participants|
|Official Title:||INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
- mortality, re-operation and infection [ Time Frame: 30 days post-hospital admission ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150980
|Contact: Silvia Li||905.527.4322 ext firstname.lastname@example.org|
|Principal Investigator:||Mohit Bhandari, MD, PhD||McMaster University|
|Principal Investigator:||Philip Devereaux, MD, PhD||McMaster University|
|Principal Investigator:||Rebecca Ivers, MPH, PhD||The George Institute|