InterNational ORthopaedic MUlticenter Study in Fracture Care
NCT ID: NCT02014974
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4822 participants
OBSERVATIONAL
2011-10-31
2012-04-30
Brief Summary
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Methods: The investigators conducted a multicenter, prospective observational study of patients sustaining fractures or dislocations who presented to an orthopaedic fracture unit at 14 hospitals in India. A representative sample of patients were recruited during an 8-week period starting on October 1, 2012. Patients were followed up to 30-days in hospital or until discharge to determine if they suffered any outcomes. Primary outcomes included total mortality, reoperation, and infection.
Detailed Description
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Global Epidemic of Trauma: Injuries from trauma accidents have been rapidly increasing in number worldwide and particularly so in developing countries. Approximately 5.8 million people die every year from traumatic injuries, accounting for 10% of the world's deaths. According to a recent report by the World Health Organization, trauma will be the third largest killer in the developing world by 2020. Moreover, for every death, several thousand individuals will suffer impairments, frequently with disabling consequences. Among the Southern Asian countries, India has the highest incidence of deaths due to physical injuries (117 deaths per 100,000 individuals). Physical injuries account for 10% of deaths, 20-25% of hospitalizations, and one third of disabilities. As this trend is growing, it is leading to an increase in the number of physical injury hospitalizations. Most developing nations, where trauma burden is escalating, have little empirical data on types of injuries, access to care, and management approaches. The investigators propose a prospective study in India (the second most populous country in the world) to examine fracture burden and provide the foundation for future collaboration and research. This study is fundamental to understanding the global burden of trauma and the design of future pragmatic randomized trials to improve function and quality of life around the world.
WHO Decade of Road Traffic Safety: This study directly aligns with the start of the Global Road Traffic Safety Decade 2011-2020 (World Health Organization), as well as our Department of Surgery's International Surgery Program. The Canadian Orthopaedic Association's 'call to action' to Canadian centers towards bridging gaps in knowledge and research in trauma in Low and Middle Income Countries further vindicates the rationale for INORMUS.
METHODS
Design Overview: Between October 2011 and March 2012, the investigators conducted a multicenter, prospective observational study of patients sustaining fractures and presenting to orthopaedic fracture units across 14 hospitals in India. 4,659 patients during an 8-week period were enrolled.
Patient characteristics, treatment, and outcome data were documented at initial consultation by a study coordinator at each hospital. Major complications, in hospital, and 30-day outcomes were evaluated.
Primary outcome
1. Logistic regression model involving 12 potential predictors of mortality;
Secondary Analyses
2. Mixed-model involving the 12 predictors of mortality to evaluate potential hospital site effects;
3. Logistic regression model looking at timing of irrigation and debridement and open fractures and deep infection rates;
4. Descriptive analyses looking at types of treatments of tibia and femur fractures across socioeconomic groups in India;
5. Descriptive analyses looking at combinations of injuries in patients involved in road traffic accidents.
Sample Size: The study enrolled 4,822 patients, and 4,612 (95.6%) of these patients completed follow-up. To include 12 predictors in the model with an estimated mortality rate among orthopedic trauma patients of 1.5%, 8000 patients are required to properly power our analysis. Based on a 20% drop out rate, 10,000 patients will be recruited in the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Public Hospitals
Patients presenting and treated in public trauma centers in India.
No interventions assigned to this group
Private Hospitals
Patients presenting and treated in private trauma centers in India.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of orthopaedic fracture or dislocation.
18 Years
ALL
No
Sponsors
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McMaster Surgical Associates
OTHER
McMaster University
OTHER
Responsible Party
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Mohit Bhandari
Professor of Surgery, Chair of Division of Orthopaedics
Principal Investigators
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Mohit Bhandari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster
Parag Sancheti, MD
Role: STUDY_DIRECTOR
Sancheti Institute for Orthopaedics
Locations
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Sancheti Institute of Orthopaedics
Pune, Maharashtra, India
Countries
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References
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Rodgers A, Ezzati M, Vander Hoorn S, Lopez AD, Lin RB, Murray CJ; Comparative Risk Assessment Collaborating Group. Distribution of major health risks: findings from the Global Burden of Disease study. PLoS Med. 2004 Oct;1(1):e27. doi: 10.1371/journal.pmed.0010027. Epub 2004 Oct 19.
Stone DH, Gofin R. The 8th World Conference on injury prevention and safety promotion. Inj Prev. 2007 Feb;13(1):70. doi: 10.1136/ip.2006.014001. No abstract available.
Joshipura MK. Trauma care in India: current scenario. World J Surg. 2008 Aug;32(8):1613-7. doi: 10.1007/s00268-008-9634-5.
Joshipura M. Guidelines for essential trauma care: progress in India. World J Surg. 2006 Jun;30(6):930-3. doi: 10.1007/s00268-005-0765-7.
Joshipura MK, Shah HS, Patel PR, Divatia PA, Desai PM. Trauma care systems in India. Injury. 2003 Sep;34(9):686-92. doi: 10.1016/s0020-1383(03)00163-3.
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.
Ma ZS, Zhang HJ, Lei W, Xiong LZ. Musculoskeletal trauma services in China. Clin Orthop Relat Res. 2008 Oct;466(10):2329-36. doi: 10.1007/s11999-008-0382-5. Epub 2008 Jul 16.
Related Links
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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
Other Identifiers
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INORMUSINDIA
Identifier Type: -
Identifier Source: org_study_id