CClinicalTrials.gg
CompletedNCT02150980INORMUSUpdated Jun 6, 2024

INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

An observational study in Fractures or Dislocations, sponsored by McMaster University. Completed at 69 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.

Sponsored by McMaster University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39,797
Ages
18 Years and older
Sex
All
01

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.

Read the 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 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.

02

Conditions studied

  • Fractures or Dislocations

Browse trials for

Keywords

  • Fractures
  • burden of fractures
  • orthopaedic fractures
  • orthopaedic injuries
  • orthopaedic trauma
  • observational study
  • outcomes of fracture care
  • epidemiology
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Eligibility 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39,797 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. mortality, re-operation and infection

    Time frame: 30 days post-hospital admission

06

Study locations

69 sites
  • Clínica Zabala
    Buenos Aires, Argentina
  • Princess Marina Hospital
    Gaborone, Botswana
  • Hospital de Beneficencia Sirio-Libanes
    San Paolo, Brazil
  • Hospital de Clínicas - UNICAMP
    São José dos Campos, Brazil
  • Baptist Hospital Mutengene
    Mutengene, Cameroon
  • Anhui Provincial Hospital
    Hefei, Anhui, China
  • Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
    Beijing, Beijing, China
  • Beijing Chaoyang Hospital
    Beijing, Beijing, China
  • Beijing Luhe Hospital
    Beijing, Beijing, China
  • Xiamen University affiliated First Hospital
    Xiamen, Fujian, China
  • Langfang Aidebao General Hospital
    Langfang, Hebei, China
  • Langfang People's Hospital
    Langfang, Hebei, China
  • Harbin Medical University Second hospital
    Harbin, Heilongjiang, China
  • Second Bethune Hospital of Jilin University
    Changchun, Jilin, China
  • Shenyang Orthopaedic Hospital
    Shenyang, Liaoning, China
  • Hanzhong People's Hospital
    Hanzhong, Shaanxi, China
  • Shanghai No.10 People's Hospital
    Shanghai, Shanghai, China
  • Tianjin Hospital
    Tianjin, Tianjin, China
  • The 2nd affiliated hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
  • Centro Médico Imbanaco
    Cali, Colombia
  • Clinica Fracturas y Fracturas
    Pereira, Colombia
  • Black Lion Hospital
    Addis Ababa, Ethiopia
  • Komfo Anokye Teaching Hospital (KATH)
    Kumasi, Ghana
  • Smt N H L Municipal Medical College
    Gujrat, Ahmedabad, India
  • Baptist Christian Hospital
    Tezpur, Assam, India
  • St John Medical College
    Bangalore, India
  • Post Graduate Institute of Medical Education and Research
    Chandigarh, India
  • AIIMs Hospital
    Delhi, India
  • Indian Institue for Spinal Care
    Delhi, India
  • CMC Ludhiana
    Ludhiana, India
  • Dr L H Hiranandani Hospital
    Mumbai, India
  • Indira Ganghi Medical College
    Puducherry, India
  • Medical College & Hospital, Bharati Vidyapeeth Deemed University
    Pune, India
  • Noble Hospital
    Pune, India
  • Sancheti Institute for Orthopaedics and Rehabilitation
    Pune, India
  • CMC Vellore
    Vellore, India
  • Data Meghe Institute of Medical Sciences
    Wardha, India
  • Sina Trauma and Surgery Research Center/University of Tehran
    Tehran, Iran, Islamic Republic of
  • Rift Valley provincial hospital
    Karuru One, Kenya
  • Kiambu District Hospital
    Kiambu, Kenya
  • AIC Kijabe Hospital
    Kijabe, Kenya
  • Kenyatta National Hospital
    Nairobi, Kenya
  • University of Malawi
    Blantyre, Malawi
  • Hospital Civil de Guadalajara
    Guadalajara, Mexico
  • Social Security Hospitals
    Guadalajara, Mexico
  • Hospital Puerta de Hierro
    Jalisco, Mexico
  • Social Security Hospitals
    Mexico City, Mexico
  • Social Security Hospital
    Monterrey, Mexico
  • Christus Muguerza Hospital Saltillo
    Saltillo, Mexico
  • Lumbini Medical College
    Kathmandu, Nepal
  • National Orthopaedic Hospital Enugu
    Enugu, Nigeria
  • State trauma and surgical centre
    Ondo, Nigeria
  • Northwest General Hospital & Research Centre
    Peshawar, Pakistan
  • Hospital Santo Tomás
    Panama city, Panama
  • Instituto de Prevision Social - Central Hospital
    Asunción, Paraguay
  • Philippine General Hospital
    Manila, Philippines
  • University Teaching Hospital
    Kigali, Rwanda
  • Charlotte Maxete Johannesburg Acadamic Hospital
    Johannesburg, South Africa
  • Chris Hani Baragwanath Acadamic Hospital
    Johannesburg, South Africa
  • Helen Joseph Hospital
    Johannesburg, South Africa
  • Muhimbili Orthopaedic Institute
    Dar es Salaam, Tanzania
  • Kilimanjaro Christian Medical Centre
    Moshi, Tanzania
  • Ramathibodi Hospital
    Bangkok, Thailand
  • Khon Kaen Hospital
    Khon Kaen, Thailand
  • Fort Portal Regional Referral Hospital
    Fort Portal, Uganda
  • Mulago Hospital, Makerere University College of Health Sciences
    Kampala, Uganda
  • Hospital Universitario de Caracas
    Caracas, Venezuela
  • Viet Duc Hospital
    Hanoi, Vietnam
  • Cho Ray Hospital
    Ho Chi Minh City, Vietnam
07

References and documents

Publications

  • Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5. PubMed 18679760 ↗
  • Fitzharris M, Zhong W, Myburgh J, Xuezhong Y, Yu J, Hammond N, Finfer SR, Taylor C, Wu Y. The status of trauma registry systems in Chinese hospitals. Inj Prev. 2011 Dec;17(6):419-21. doi: 10.1136/injuryprev-2011-040216. Epub 2011 Oct 13. PubMed 21998256 ↗
  • Fitzharris M, Yu J, Hammond N, Taylor C, Wu Y, Finfer S, Myburgh J. Injury in China: a systematic review of injury surveillance studies conducted in Chinese hospital emergency departments. BMC Emerg Med. 2011 Oct 26;11:18. doi: 10.1186/1471-227X-11-18. PubMed 22029774 ↗
  • Bhalla K, Harrison JE, Shahraz S, Fingerhut LA; Global Burden of Disease Injury Expert Group. Availability and quality of cause-of-death data for estimating the global burden of injuries. Bull World Health Organ. 2010 Nov 1;88(11):831-838C. doi: 10.2471/BLT.09.068809. Epub 2010 Jun 22. PubMed 21076564 ↗
  • 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.
  • INORMUS Investigators. INternational ORthopaedic MUlticentre Study (INORMUS) in Fracture Care: Protocol for a Large Prospective Observational Study. J Orthop Trauma. 2015 Oct;29 Suppl 10:S2-6. doi: 10.1097/BOT.0000000000000404. PubMed 26356208 ↗
  • Foote CJ, Mundi R, Sancheti P, Gopalan H, Kotwal P, Shetty V, Dhillon M, Devereaux P, Thabane L, Aleem I, Ivers RQ, Bhandari M; INORMUS Investigators. Musculoskeletal trauma and all-cause mortality in India: a multicentre prospective cohort study. Lancet. 2015 Apr 27;385 Suppl 2:S30. doi: 10.1016/S0140-6736(15)60825-X. Epub 2015 Apr 26. PubMed 26313078 ↗
  • INORMUS Investigative Committee on behalf of all INORMUS Investigators. Operationalizing an orthopaedic research plan in the Decade of Action for Road Safety: the INternational ORthopaedic MUlticenter Study in Fracture Care. J Orthop Trauma. 2014;28 Suppl 1:S29. doi: 10.1097/BOT.0000000000000119. No abstract available. PubMed 24857994 ↗
  • Pouramin P, Li CS, Busse JW, Sprague S, Devereaux PJ, Jagnoor J, Ivers R, Bhandari M; INORMUS investigators. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study. Lancet Glob Health. 2020 May;8(5):e711-e720. doi: 10.1016/S2214-109X(20)30067-X. PubMed 32353318 ↗
08

Registry details

Key details

Study ID
NCT02150980
Lead sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McMaster Surgical Associates, National Health and Medical Research Council, Australia, Hamilton Health Sciences Corporation
Responsible party
Mohit Bhandari (Professor of Surgery, Chair of Division of Orthopaedics, McMaster University) — Principal investigator
First posted
May 30, 2014
Start date
Apr 2014
Primary completion
Nov 2023
Completion
Nov 2023
Last update
Jun 6, 2024

Study contacts

Mohit Bhandari, MD, PhD
principal investigator · McMaster University
Philip Devereaux, MD, PhD
principal investigator · McMaster University
Rebecca Ivers, MPH, PhD
principal investigator · The George Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion