Fractures or Dislocations Clinical Trial
— INORMUSOfficial title:
INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
| Verified date | June 2024 |
| Source | McMaster University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 39797 |
| Est. completion date | November 2023 |
| Est. primary completion date | November 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Clínica Zabala | Buenos Aires | |
| Botswana | Princess Marina Hospital | Gaborone | |
| Brazil | Hospital de Beneficencia Sirio-Libanes | San Paolo | |
| Brazil | Hospital de Clínicas - UNICAMP | São José dos Campos | |
| Cameroon | Baptist Hospital Mutengene | Mutengene | |
| 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 | Second Bethune Hospital of Jilin University | Changchun | Jilin |
| China | Hanzhong People's Hospital | Hanzhong | Shaanxi |
| China | Harbin Medical University Second hospital | Harbin | Heilongjiang |
| China | Anhui Provincial Hospital | Hefei | Anhui |
| China | Langfang Aidebao General Hospital | Langfang | Hebei |
| China | Langfang People's Hospital | Langfang | Hebei |
| China | Shanghai No.10 People's Hospital | Shanghai | Shanghai |
| China | Shenyang Orthopaedic Hospital | Shenyang | Liaoning |
| China | Tianjin Hospital | Tianjin | Tianjin |
| China | The 2nd affiliated hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
| China | Xiamen University affiliated First Hospital | Xiamen | Fujian |
| Colombia | Centro Médico Imbanaco | Cali | |
| Colombia | Clinica Fracturas y Fracturas | Pereira | |
| Ethiopia | Black Lion Hospital | Addis Ababa | |
| Ghana | Komfo Anokye Teaching Hospital (KATH) | Kumasi | |
| 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 | Smt N H L Municipal Medical College | Gujrat | Ahmedabad |
| 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 | Baptist Christian Hospital | Tezpur | Assam |
| India | CMC Vellore | Vellore | |
| India | Data Meghe Institute of Medical Sciences | Wardha | |
| Iran, Islamic Republic of | Sina Trauma and Surgery Research Center/University of Tehran | Tehran | |
| Kenya | Rift Valley provincial hospital | Karuru One | |
| Kenya | Kiambu District Hospital | Kiambu | |
| Kenya | AIC Kijabe Hospital | Kijabe | |
| Kenya | Kenyatta National Hospital | Nairobi | |
| Malawi | University of Malawi | Blantyre | |
| Mexico | 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 | |
| Nepal | Lumbini Medical College | Kathmandu | |
| Nigeria | National Orthopaedic Hospital Enugu | Enugu | |
| Nigeria | State trauma and surgical centre | Ondo | |
| Pakistan | Northwest General Hospital & Research Centre | Peshawar | |
| Panama | Hospital Santo Tomás | Panama city | |
| Paraguay | Instituto de Prevision Social - Central Hospital | Asunción | |
| Philippines | Philippine General Hospital | Manila | |
| Rwanda | University Teaching Hospital | Kigali | |
| South Africa | Charlotte Maxete Johannesburg Acadamic Hospital | Johannesburg | |
| South Africa | Chris Hani Baragwanath Acadamic Hospital | Johannesburg | |
| South Africa | Helen Joseph Hospital | Johannesburg | |
| Tanzania | Muhimbili Orthopaedic Institute | Dar es Salaam | |
| Tanzania | Kilimanjaro Christian Medical Centre | Moshi | |
| Thailand | Ramathibodi Hospital | Bangkok | |
| Thailand | Khon Kaen Hospital | Khon Kaen | |
| Uganda | Fort Portal Regional Referral Hospital | Fort Portal | |
| Uganda | Mulago Hospital, Makerere University College of Health Sciences | Kampala | |
| Venezuela | Hospital Universitario de Caracas | Caracas | |
| Vietnam | Viet Duc Hospital | Hanoi | |
| Vietnam | Cho Ray Hospital | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| McMaster University | Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation, McMaster Surgical Associates, National Health and Medical Research Council, Australia |
Argentina, Botswana, Brazil, Cameroon, China, Colombia, Ethiopia, Ghana, India, Iran, Islamic Republic of, Kenya, Malawi, Mexico, Nepal, Nigeria, Pakistan, Panama, Paraguay, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Venezuela, Vietnam,
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. — View 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. — View 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. — View 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. — View 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.
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mortality, re-operation and infection | 30 days post-hospital admission |