Clinical trial NCT02150980: INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)
Official title: INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures or Dislocations
Keywords: Fractures
burden of fractures
orthopaedic fractures
orthopaedic injuries
orthopaedic trauma
observational study
outcomes of fracture care
epidemiology
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McMaster Surgical Associates
name: National Health and Medical Research Council, Australia
name: Hamilton Health Sciences Corporation
First posted: 2014-05-30
Enrollment: 39797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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.

Primary outcomes:
measure: mortality, re-operation and infection
timeFrame: 30 days post-hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clínica Zabala
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
city: San Paolo
country: Brazil
facility: Hospital de Beneficencia Sirio-Libanes
city: São José dos Campos
country: Brazil
facility: Hospital de Clínicas - UNICAMP
city: Mutengene
country: Cameroon
facility: Baptist Hospital Mutengene
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen University affiliated First Hospital
state: Fujian
city: Langfang
country: China
facility: Langfang Aidebao General Hospital
state: Hebei
city: Langfang
country: China
facility: Langfang People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Second hospital
state: Heilongjiang
city: Changchun
country: China
facility: Second Bethune Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shenyang Orthopaedic Hospital
state: Liaoning
city: Hanzhong
country: China
facility: Hanzhong People's Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai No.10 People's Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Hospital
state: Tianjin
city: Wenzhou
country: China
facility: The 2nd affiliated hospital of Wenzhou Medical University
state: Zhejiang
city: Cali
country: Colombia
facility: Centro Médico Imbanaco
city: Pereira
country: Colombia
facility: Clinica Fracturas y Fracturas
city: Addis Ababa
country: Ethiopia
facility: Black Lion Hospital
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital (KATH)
city: Gujrat
country: India
facility: Smt N H L Municipal Medical College
state: Ahmedabad
city: Tezpur
country: India
facility: Baptist Christian Hospital
state: Assam
city: Bangalore
country: India
facility: St John Medical College
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Delhi
country: India
facility: AIIMs Hospital
city: Delhi
country: India
facility: Indian Institue for Spinal Care
city: Ludhiana
country: India
facility: CMC Ludhiana
city: Mumbai
country: India
facility: Dr L H Hiranandani Hospital
city: Puducherry
country: India
facility: Indira Ganghi Medical College
city: Pune
country: India
facility: Medical College & Hospital, Bharati Vidyapeeth Deemed University
city: Pune
country: India
facility: Noble Hospital
city: Pune
country: India
facility: Sancheti Institute for Orthopaedics and Rehabilitation
city: Vellore
country: India
facility: CMC Vellore
city: Wardha
country: India
facility: Data Meghe Institute of Medical Sciences
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Trauma and Surgery Research Center/University of Tehran
city: Karuru One
country: Kenya
facility: Rift Valley provincial hospital
city: Kiambu
country: Kenya
facility: Kiambu District Hospital
city: Kijabe
country: Kenya
facility: AIC Kijabe Hospital
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
city: Blantyre
country: Malawi
facility: University of Malawi
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
city: Guadalajara
country: Mexico
facility: Social Security Hospitals
city: Jalisco
country: Mexico
facility: Hospital Puerta de Hierro
city: Mexico City
country: Mexico
facility: Social Security Hospitals
city: Monterrey
country: Mexico
facility: Social Security Hospital
city: Saltillo
country: Mexico
facility: Christus Muguerza Hospital Saltillo
city: Kathmandu
country: Nepal
facility: Lumbini Medical College
city: Enugu
country: Nigeria
facility: National Orthopaedic Hospital Enugu
city: Ondo
country: Nigeria
facility: State trauma and surgical centre
city: Peshawar
country: Pakistan
facility: Northwest General Hospital & Research Centre
city: Panama city
country: Panama
facility: Hospital Santo Tomás
city: Asunción
country: Paraguay
facility: Instituto de Prevision Social - Central Hospital
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Kigali
country: Rwanda
facility: University Teaching Hospital
city: Johannesburg
country: South Africa
facility: Charlotte Maxete Johannesburg Acadamic Hospital
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Acadamic Hospital
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital
city: Dar es Salaam
country: Tanzania
facility: Muhimbili Orthopaedic Institute
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Fort Portal
country: Uganda
facility: Fort Portal Regional Referral Hospital
city: Kampala
country: Uganda
facility: Mulago Hospital, Makerere University College of Health Sciences
city: Caracas
country: Venezuela
facility: Hospital Universitario de Caracas
city: Hanoi
country: Vietnam
facility: Viet Duc Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Philip Devereaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute
name: Rebecca Ivers, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.