INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

Last updated: June 5, 2024
Sponsor: McMaster University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02150980
INORMUS_INTERNATIONAL
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 39797
Study Start date:
April 01, 2014
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Clínica Zabala

    Buenos Aires,
    Argentina

    Site Not Available

  • Princess Marina Hospital

    Gaborone,
    Botswana

    Site Not Available

  • Hospital de Beneficencia Sirio-Libanes

    San Paolo,
    Brazil

    Site Not Available

  • Hospital de Clínicas - UNICAMP

    São José dos Campos,
    Brazil

    Site Not Available

  • Baptist Hospital Mutengene

    Mutengene,
    Cameroon

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Chaoyang Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Luhe Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Xiamen University affiliated First Hospital

    Xiamen, Fujian
    China

    Site Not Available

  • Guangzhou Development District Hospital

    Guang Zhou, Guangdong
    China

    Site Not Available

  • Langfang Aidebao General Hospital

    Langfang, Hebei
    China

    Site Not Available

  • Langfang People's Hospital

    Langfang, Hebei
    China

    Site Not Available

  • Harbin Medical University Second hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Second Bethune Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Shenyang Orthopaedic Hospital

    Shenyang, Liaoning
    China

    Site Not Available

  • Hanzhong People's Hospital

    Hanzhong, Shaanxi
    China

    Site Not Available

  • Shanghai No.10 People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Tianjin Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • The 2nd affiliated hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Centro Médico Imbanaco

    Cali,
    Colombia

    Site Not Available

  • Clinica Fracturas y Fracturas

    Pereira,
    Colombia

    Site Not Available

  • Black Lion Hospital

    Addis Ababa,
    Ethiopia

    Site Not Available

  • Komfo Anokye Teaching Hospital (KATH)

    Kumasi,
    Ghana

    Site Not Available

  • Smt N H L Municipal Medical College

    Gujrat, Ahmedabad
    India

    Site Not Available

  • Baptist Christian Hospital

    Tezpur, Assam
    India

    Site Not Available

  • St John Medical College

    Bangalore,
    India

    Site Not Available

  • Post Graduate Institute of Medical Education and Research

    Chandigarh,
    India

    Site Not Available

  • AIIMs Hospital

    Delhi,
    India

    Site Not Available

  • Indian Institue for Spinal Care

    Delhi,
    India

    Site Not Available

  • CMC Ludhiana

    Ludhiana,
    India

    Site Not Available

  • Dr L H Hiranandani Hospital

    Mumbai,
    India

    Site Not Available

  • Indira Ganghi Medical College

    Puducherry,
    India

    Site Not Available

  • Medical College & Hospital, Bharati Vidyapeeth Deemed University

    Pune,
    India

    Site Not Available

  • Noble Hospital

    Pune,
    India

    Site Not Available

  • Sancheti Institute for Orthopaedics and Rehabilitation

    Pune,
    India

    Site Not Available

  • CMC Vellore

    Vellore,
    India

    Site Not Available

  • Data Meghe Institute of Medical Sciences

    Wardha,
    India

    Site Not Available

  • Sina Trauma and Surgery Research Center/University of Tehran

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

  • Rift Valley provincial hospital

    Kakuru,
    Kenya

    Site Not Available

  • Rift Valley provincial hospital

    Karuru One,
    Kenya

    Site Not Available

  • Kiambu District Hospital

    Kiambu,
    Kenya

    Site Not Available

  • AIC Kijabe Hospital

    Kijabe,
    Kenya

    Site Not Available

  • Kenyatta National Hospital

    Nairobi,
    Kenya

    Site Not Available

  • University of Malawi

    Blantyre,
    Malawi

    Site Not Available

  • Hospital Civil de Guadalajara

    Guadalajara,
    Mexico

    Site Not Available

  • Social Security Hospitals

    Guadalajara,
    Mexico

    Site Not Available

  • Hospital Puerta de Hierro

    Jalisco,
    Mexico

    Site Not Available

  • Social Security Hospitals

    Mexico City,
    Mexico

    Site Not Available

  • Social Security Hospital

    Monterrey,
    Mexico

    Site Not Available

  • Christus Muguerza Hospital Saltillo

    Saltillo,
    Mexico

    Site Not Available

  • Lumbini Medical College

    Kathmandu,
    Nepal

    Site Not Available

  • National Orthopaedic Hospital Enugu

    Enugu,
    Nigeria

    Site Not Available

  • State trauma and surgical centre

    Ondo,
    Nigeria

    Site Not Available

  • Northwest General Hospital & Research Centre

    Peshawar,
    Pakistan

    Site Not Available

  • Hospital Santo Tomás

    Panama city,
    Panama

    Site Not Available

  • Instituto de Prevision Social - Central Hospital

    Asunción,
    Paraguay

    Site Not Available

  • Philippine General Hospital

    Manila,
    Philippines

    Site Not Available

  • University Teaching Hospital

    Kigali,
    Rwanda

    Site Not Available

  • University of Cape Town

    Cape Town,
    South Africa

    Site Not Available

  • Charlotte Maxete Johannesburg Acadamic Hospital

    Johannesburg,
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Acadamic Hospital

    Johannesburg,
    South Africa

    Site Not Available

  • Helen Joseph Hospital

    Johannesburg,
    South Africa

    Site Not Available

  • Muhimbili Orthopaedic Institute

    Dar es Salaam,
    Tanzania

    Site Not Available

  • Kilimanjaro Christian Medical Centre

    Moshi,
    Tanzania

    Site Not Available

  • Ramathibodi Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Khon Kaen Hospital

    Khon Kaen,
    Thailand

    Site Not Available

  • Fort Portal Regional Referral Hospital

    Fort Portal,
    Uganda

    Site Not Available

  • Mulago Hospital, Makerere University College of Health Sciences

    Kampala,
    Uganda

    Site Not Available

  • Hospital Universitario de Caracas

    Caracas,
    Venezuela

    Site Not Available

  • Viet Duc Hospital

    Hannoi,
    Vietnam

    Site Not Available

  • Viet Duc Hospital

    Hanoi,
    Vietnam

    Site Not Available

  • Cho Ray Hospital

    Ho Chi Minh,
    Vietnam

    Site Not Available

  • Cho Ray Hospital

    Ho Chi Minh City,
    Vietnam

    Site Not Available

  • [TBD]

    [tbd],
    Zimbabwe

    Site Not Available

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