INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS) (INORMUS)

March 12, 2024 updated by: Mohit Bhandari, McMaster University

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

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.

Study Overview

Status

Completed

Conditions

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 as individual components 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).

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.

Study Type

Observational

Enrollment (Actual)

39797

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Botswana
      • Gaborone, Botswana
        • Princess Marina Hospital
  • Brazil
      • São José dos Campos, Brazil
        • Hospital de Clínicas - UNICAMP
  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China
        • Beijing Chaoyang Hospital
      • Beijing, Beijing, China
        • Beijing luhe hospital
      • Beijing, Beijing, China
        • Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
    • Fujian
      • Xiamen, Fujian, China
        • Xiamen University affiliated First Hospital
    • Hebei
      • Langfang, Hebei, China
        • Langfang Aidebao General Hospital
      • Langfang, Hebei, China
        • Langfang People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Second hospital
    • Jilin
      • Changchun, Jilin, China
        • Second Bethune Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shenyang Orthopaedic Hospital
    • Shaanxi
      • Hanzhong, Shaanxi, China
        • Hanzhong People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai No.10 People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • The 2nd affiliated hospital of Wenzhou Medical University
  • Ethiopia
      • Addis Ababa, Ethiopia
        • Black Lion Hospital
  • Ghana
      • Kumasi, Ghana
        • Komfo Anokye Teaching Hospital (KATH)
  • India
      • Bangalore, India
        • St John Medical College
      • Chandigarh, India
        • Post Graduate Institute of Medical Education and Research
      • Delhi, India
        • AIIMS Hospital
      • Delhi, India
        • Indian Institue for Spinal Care
      • Ludhiana, India
        • CMC Ludhiana
      • Mumbai, India
        • Dr L H Hiranandani Hospital
      • Puducherry, India
        • Indira Ganghi Medical College
      • Pune, India
        • Noble Hospital
      • Pune, India
        • Sancheti Institute for Orthopaedics and Rehabilitation
      • Pune, India
        • Medical College & Hospital, Bharati Vidyapeeth Deemed University
      • Vellore, India
        • CMC Vellore
      • Wardha, India
        • Data Meghe Institute of Medical Sciences
  • Kenya
      • Karuru One, Kenya
        • Rift Valley provincial hospital
      • Kiambu, Kenya
        • Kiambu District Hospital
      • Kijabe, Kenya
        • AIC Kijabe Hospital
      • Nairobi, Kenya
        • Kenyatta National Hospital
  • Malawi
      • Blantyre, Malawi
        • University of Malawi
  • Mexico
      • Guadalajara, Mexico
        • Hospital Civil de Guadalajara
      • Guadalajara, Mexico
        • Social Security Hospitals
      • Mexico City, Mexico
        • Social Security Hospitals
      • Monterrey, Mexico
        • Social Security Hospital
  • Nepal
      • Kathmandu, Nepal
        • Lumbini Medical College
  • Nigeria
      • Ondo, Nigeria
        • State trauma and surgical centre
  • Pakistan
      • Peshawar, Pakistan
        • Northwest General Hospital & Research Centre
  • Rwanda
      • Kigali, Rwanda
        • University Teaching Hospital
  • South Africa
      • Johannesburg, South Africa
        • Helen Joseph Hospital
      • Johannesburg, South Africa
        • Charlotte Maxete Johannesburg Acadamic Hospital
      • Johannesburg, South Africa
        • Chris Hani Baragwanath Acadamic Hospital
  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili Orthopaedic Institute
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre
  • Uganda
      • Fort Portal, Uganda
        • Fort Portal Regional Referral Hospital
      • Kampala, Uganda
        • Mulago Hospital, Makerere University College of Health Sciences
  • Vietnam
      • Hanoi, Vietnam
        • Viet Duc Hospital
      • Ho Chi Minh City, Vietnam
        • Cho Ray Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients 18 years of age or older who are admitted to a recruiting hospital in low-middle income countries in Africa, Asia, and Latin America

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

National Health and Medical Research Council, Australia
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
McMaster Surgical Associates

Investigators

  • Principal Investigator: Philip Devereaux, MD, PhD, McMaster University
  • Principal Investigator: Rebecca Ivers, MPH, PhD, The George Institute
  • Principal Investigator: Mohit Bhandari, MD, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimated)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INORMUS_INTERNATIONAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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