Clinical trial NCT02014974: InterNational ORthopaedic MUlticenter Study in Fracture Care
Official title: INORMUS 5,000: Large Observational Study of Orthopedic Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Fractures
Keywords: Fractures
burden of fractures
orthopaedic fractures
orthopaedic injuries
orthopaedic trauma
fractures India
observational study
outcomes of fracture care
wait times India
epidemiology
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2013-12-19
Enrollment: 4822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We have planned a multicenter, prospective observational study of patients sustaining fractures and presenting to orthopaedic fracture units across hospitals in India. All patients with an orthopaedic injury presenting participating hospitals during an 8-week period will be approached for study enrolment.

Brief summary: 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.

Detailed description: INTRODUCTION

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.

Eligibility criteria: Inclusion Criteria:

1. Over 17 years old;
2. Diagnosis of orthopaedic fracture or dislocation.

Primary outcomes:
measure: 30-day Mortality
timeFrame: 30 days post injury
Secondary outcomes:
measure: Deep Infection
timeFrame: 30 days post-injury
Other outcomes:
Locations:
city: Pune
country: India
facility: Sancheti Institute of Orthopaedics
state: Maharashtra
Study officials:
affiliation: McMaster
name: Mohit Bhandari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sancheti Institute for Orthopaedics
name: Parag Sancheti, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1371/journal.pmed.0010027. Epub 2004 Oct 19.
citation: 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.
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.
citation: 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.
citation: 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.
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.
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.