InterNational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

September 29, 2017 updated by: Mohit Bhandari, McMaster University

INORMUS 5,000: Large Observational Study of Orthopedic Trauma Patients

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

4822

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411005
        • Sancheti Institute of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Public Hospitals
Patients presenting and treated in public trauma centers in India.
Private Hospitals
Patients presenting and treated in private trauma centers in India.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Mortality
Time Frame: 30 days post injury
Logistic regression including 12 a priori predictors of mortality.
30 days post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep Infection
Time Frame: 30 days post-injury
Logistic regression including 8 a priori predictors of deep infection in open fracture patients.
30 days post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

McMaster Surgical Associates

Investigators

  • Principal Investigator: Mohit Bhandari, MD, PhD, Mcmaster
  • Study Director: Parag Sancheti, MD, Sancheti Institute for Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INORMUSINDIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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