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NCT01544725
Dislocation, Fracture
Nice, France
View Trial DetailsNCT Number: NCT02150980
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.
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Notify Me18 year and older
All sexes
Observational
Clínica Zabala, Buenos Aires, Argentina
Number of Participants:
40,000
Primary Research Objectives:
To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: 30 days post-hospital admission
McMaster University
Other
INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
Acronym: INORMUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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