Bone Fractures Clinical Trial
— INORMUSOfficial title:
INORMUS 5,000: Large Observational Study of Orthopedic Trauma Patients
Verified date | September 2017 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Worldwide injuries from trauma accidents represents a major population problem.
The World Health Organization (WHO) has deemed this problem as one of the most important
global priorities, calling 2011-2021 the Global Road Traffic Safety Decade. Despite this,
there is little empirical data in low and middle-income countries quantifying the burden of
fractures and the current practice of care.
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.
Status | Completed |
Enrollment | 4822 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Over 17 years old; 2. Diagnosis of orthopaedic fracture or dislocation. |
Country | Name | City | State |
---|---|---|---|
India | Sancheti Institute of Orthopaedics | Pune | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
McMaster University | McMaster Surgical Associates |
India,
Joshipura M. Guidelines for essential trauma care: progress in India. World J Surg. 2006 Jun;30(6):930-3. — View Citation
Joshipura MK, Shah HS, Patel PR, Divatia PA, Desai PM. Trauma care systems in India. Injury. 2003 Sep;34(9):686-92. — View Citation
Joshipura MK. Trauma care in India: current scenario. World J Surg. 2008 Aug;32(8):1613-7. doi: 10.1007/s00268-008-9634-5. — View Citation
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. Review. — 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. Review. — View Citation
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. Epub 2004 Oct 19. — View Citation
Stone DH, Gofin R. The 8th World Conference on injury prevention and safety promotion. Inj Prev. 2007 Feb;13(1):70. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day Mortality | Logistic regression including 12 a priori predictors of mortality. | 30 days post injury | |
Secondary | Deep Infection | Logistic regression including 8 a priori predictors of deep infection in open fracture patients. | 30 days post-injury |
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