INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

NCT02150980 | Completed DMC

• 1 other identifier: INORMUS_INTERNATIONAL
• Study Type: observational
• Target: 39,797
• Locations: 24 countries
• Sites: 67

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.

Conditions

Fractures or Dislocations

Keywords

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

Outcome Measures

Primary Outcomes (1)

• mortality, re-operation and infection

  30 days post-hospital admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (69)

Clínica Zabala

Buenos Aires, Argentina

Location

Princess Marina Hospital

Gaborone, Botswana

Location

Hospital de Clínicas - UNICAMP

São José dos Campos, Brazil

Location

Hospital de Beneficencia Sirio-Libanes

São Paulo, Brazil

Location

Baptist Hospital Mutengene

Mutengene, Cameroon

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Location

Beijing Luhe Hospital

Beijing, Beijing Municipality, China

Location

Xiamen University affiliated First Hospital

Xiamen, Fujian, China

Location

Langfang Aidebao General Hospital

Langfang, Hebei, China

Location

Langfang People's Hospital

Langfang, Hebei, China

Location

Harbin Medical University Second hospital

Harbin, Heilongjiang, China

Location

Second Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Shenyang Orthopaedic Hospital

Shenyang, Liaoning, China

Location

Hanzhong People's Hospital

Hanzhong, Shaanxi, China

Location

Shanghai No.10 People's Hospital

Shanghai, Shanghai Municipality, China

Location

Tianjin Hospital

Tianjin, Tianjin Municipality, China

Location

The 2nd affiliated hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Centro Médico Imbanaco

Cali, Colombia

Location

Clinica Fracturas y Fracturas

Pereira, Colombia

Location

Black Lion Hospital

Addis Ababa, Ethiopia

Location

Komfo Anokye Teaching Hospital (KATH)

Kumasi, Ghana

Location

Smt N H L Municipal Medical College

Gujrāt, Ahmedabad, India

Location

Baptist Christian Hospital

Tezpur, Assam, India

Location

St John Medical College

Bangalore, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Location

AIIMs Hospital

Delhi, India

Location

Indian Institue for Spinal Care

Delhi, India

Location

CMC Ludhiana

Ludhiana, India

Location

Dr L H Hiranandani Hospital

Mumbai, India

Location

Indira Ganghi Medical College

Puducherry, India

Location

Medical College & Hospital, Bharati Vidyapeeth Deemed University

Pune, India

Location

Noble Hospital

Pune, India

Location

Sancheti Institute for Orthopaedics and Rehabilitation

Pune, India

Location

CMC Vellore

Vellore, India

Location

Data Meghe Institute of Medical Sciences

Wardha, India

Location

Sina Trauma and Surgery Research Center/University of Tehran

Tehran, Iran

Location

Rift Valley provincial hospital

Karuru One, Kenya

Location

Kiambu District Hospital

Kiambu, Kenya

Location

AIC Kijabe Hospital

Kijabe, Kenya

Location

Kenyatta National Hospital

Nairobi, Kenya

Location

University of Malawi

Blantyre, Malawi

Location

Hospital Civil de Guadalajara

Guadalajara, Mexico

Location

Social Security Hospitals

Guadalajara, Mexico

Location

Hospital Puerta de Hierro

Jalisco, Mexico

Location

Social Security Hospitals

Mexico City, Mexico

Location

Social Security Hospital

Monterrey, Mexico

Location

Christus Muguerza Hospital Saltillo

Saltillo, Mexico

Location

Lumbini Medical College

Kathmandu, Nepal

Location

National Orthopaedic Hospital Enugu

Enugu, Nigeria

Location

State trauma and surgical centre

Ondo, Nigeria

Location

Northwest General Hospital & Research Centre

Peshawar, Pakistan

Location

Hospital Santo Tomás

Panama City, Panama

Location

Instituto de Prevision Social - Central Hospital

Asunción, Paraguay

Location

Philippine General Hospital

Manila, Philippines

Location

University Teaching Hospital

Kigali, Rwanda

Location

Charlotte Maxete Johannesburg Acadamic Hospital

Johannesburg, South Africa

Location

Chris Hani Baragwanath Acadamic Hospital

Johannesburg, South Africa

Location

Helen Joseph Hospital

Johannesburg, South Africa

Location

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Khon Kaen Hospital

Khon Kaen, Thailand

Location

Fort Portal Regional Referral Hospital

Fort Portal, Uganda

Location

Mulago Hospital, Makerere University College of Health Sciences

Kampala, Uganda

Location

Hospital Universitario de Caracas

Caracas, Venezuela

Location

Viet Duc Hospital

Hanoi, Vietnam

Location

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (9)

• 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.

  PMID: 18679760 BACKGROUND

• 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.

  PMID: 21998256 BACKGROUND

• 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.

  PMID: 22029774 BACKGROUND

• 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.

  PMID: 21076564 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26356208 BACKGROUND

• 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.

  PMID: 26313078 BACKGROUND

• 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.

  PMID: 24857994 BACKGROUND

• 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.

  PMID: 32353318 DERIVED

Related Links

• United Nations Global Road Traffic Safety Collaboration
• Canadian Orthopaedic Association: Call for Action Group
• WHO's Make Roads Safe Campaign
• McMaster University International Surgery Desk

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Mohit Bhandari, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Philip Devereaux, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Rebecca Ivers, MPH, PhD

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Chair of Division of Orthopaedics

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

IN (14); CN (14); CO (2); KE (4); TA (2); ME (6); AR (1); TH (2); VN (2); CA (1); GH (1); IR (1); ET (1); PH (1); NG (2); ZA (3); VE (1); UG (2); BO (1); PA (1); NE (1); RW (1); MA (1); BR (2)