INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)
- Conditions
- Fractures or Dislocations
- Registration Number
- NCT02150980
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39797
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortality, re-operation and infection 30 days post-hospital admission
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
ClÃnica Zabala
🇦🇷Buenos Aires, Argentina
Indira Ganghi Medical College
🇮🇳Puducherry, India
Philippine General Hospital
🇵ðŸ‡Manila, Philippines
Hospital de Beneficencia Sirio-Libanes
🇧🇷San Paolo, Brazil
Charlotte Maxete Johannesburg Acadamic Hospital
🇿🇦Johannesburg, South Africa
Princess Marina Hospital
🇧🇼Gaborone, Botswana
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Clinica Fracturas y Fracturas
🇨🇴Pereira, Colombia
Black Lion Hospital
🇪🇹Addis Ababa, Ethiopia
Baptist Christian Hospital
🇮🇳Tezpur, Assam, India
St John Medical College
🇮🇳Bangalore, India
Komfo Anokye Teaching Hospital (KATH)
🇬ðŸ‡Kumasi, Ghana
Chris Hani Baragwanath Acadamic Hospital
🇿🇦Johannesburg, South Africa
Noble Hospital
🇮🇳Pune, India
Sancheti Institute for Orthopaedics and Rehabilitation
🇮🇳Pune, India
Sina Trauma and Surgery Research Center/University of Tehran
🇮🇷Tehran, Iran, Islamic Republic of
Viet Duc Hospital
🇻🇳Hanoi, Vietnam
Cho Ray Hospital
🇻🇳Ho Chi Minh City, Vietnam
Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Hospital de ClÃnicas - UNICAMP
🇧🇷São José dos Campos, Brazil
Shanghai No.10 People's Hospital
🇨🇳Shanghai, Shanghai, China
Medical College & Hospital, Bharati Vidyapeeth Deemed University
🇮🇳Pune, India
Rift Valley provincial hospital
🇰🇪Karuru One, Kenya
Kiambu District Hospital
🇰🇪Kiambu, Kenya
Hospital Santo Tomás
🇵🇦Panama city, Panama
Helen Joseph Hospital
🇿🇦Johannesburg, South Africa
Muhimbili Orthopaedic Institute
🇹🇿Dar es Salaam, Tanzania
Ramathibodi Hospital
🇹ðŸ‡Bangkok, Thailand
Beijing Chaoyang 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
Beijing Luhe Hospital
🇨🇳Beijing, Beijing, China
Harbin Medical University Second hospital
🇨🇳Harbin, Heilongjiang, China
Second Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Hanzhong People's Hospital
🇨🇳Hanzhong, Shaanxi, China
Shenyang Orthopaedic Hospital
🇨🇳Shenyang, Liaoning, China
Tianjin Hospital
🇨🇳Tianjin, Tianjin, China
The 2nd affiliated hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Mulago Hospital, Makerere University College of Health Sciences
🇺🇬Kampala, Uganda
Fort Portal Regional Referral Hospital
🇺🇬Fort Portal, Uganda
University of Malawi
🇲🇼Blantyre, Malawi
National Orthopaedic Hospital Enugu
🇳🇬Enugu, Nigeria
Instituto de Prevision Social - Central Hospital
🇵🇾Asunción, Paraguay
Hospital Puerta de Hierro
🇲🇽Jalisco, Mexico
CMC Vellore
🇮🇳Vellore, India
Centro Médico Imbanaco
🇨🇴Cali, Colombia
Dr L H Hiranandani Hospital
🇮🇳Mumbai, India
AIC Kijabe Hospital
🇰🇪Kijabe, Kenya
Christus Muguerza Hospital Saltillo
🇲🇽Saltillo, Mexico
Lumbini Medical College
🇳🇵Kathmandu, Nepal
Kilimanjaro Christian Medical Centre
🇹🇿Moshi, Tanzania
AIIMs Hospital
🇮🇳Delhi, India
Indian Institue for Spinal Care
🇮🇳Delhi, India
Social Security Hospitals
🇲🇽Mexico City, Mexico
Hospital Civil de Guadalajara
🇲🇽Guadalajara, Mexico
Smt N H L Municipal Medical College
🇮🇳Gujrat, Ahmedabad, India
Data Meghe Institute of Medical Sciences
🇮🇳Wardha, India
Baptist Hospital Mutengene
🇨🇲Mutengene, Cameroon
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
University Teaching Hospital
🇷🇼Kigali, Rwanda
Hospital Universitario de Caracas
🇻🇪Caracas, Venezuela
CMC Ludhiana
🇮🇳Ludhiana, India
Social Security Hospital
🇲🇽Monterrey, Mexico
State trauma and surgical centre
🇳🇬Ondo, Nigeria
Northwest General Hospital & Research Centre
🇵🇰Peshawar, Pakistan
Khon Kaen Hospital
🇹ðŸ‡Khon Kaen, Thailand
Kenyatta National Hospital
🇰🇪Nairobi, Kenya