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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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
National Health and Medical Research Council, Australia
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Mohit Bhandari, 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.


Condition or disease
Fractures or Dislocations

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.


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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures




Primary Outcome Measures :
  1. mortality, re-operation and infection [ Time Frame: 30 days post-hospital admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Silvia Li 905.527.4322 ext 44981 silviali@mcmaster.ca

  Show 52 Study Locations
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
National Health and Medical Research Council, Australia
Hamilton Health Sciences Corporation
Investigators
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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

Additional Information:
Publications:
Foote CJ, Petrisor B, Beyene J, Devereaux PJ, Dhillon M, Sancheti P Kotwal P, Miclau T, Bhandari M, and the INORMUS Investigators. International Orthopaedic Multicenter Fracture Study (INORMUS). Paper presented at: Orthopaedic Trauma Association 2012 Annual Meeting; 2012 October 3-6; Minneapolis, Minnesota.

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Responsible Party: Mohit Bhandari, Professor of Surgery, Chair of Division of Orthopaedics, McMaster University
ClinicalTrials.gov Identifier: NCT02150980     History of Changes
Other Study ID Numbers: INORMUS_INTERNATIONAL
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

Keywords provided by Mohit Bhandari, McMaster University:
Fractures
burden of fractures
orthopaedic fractures
orthopaedic injuries
orthopaedic trauma
observational study
outcomes of fracture care
epidemiology

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries