Bone FracturesINORMUSNCT02014974
InterNational ORthopaedic MUlticenter Study in Fracture Care
An observational study of Bone Fractures, run by McMaster University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fractures
- How many people
- 4,822 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Over 17 years old;
- Diagnosis of orthopaedic fracture or dislocation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Logistic regression model involving 12 potential predictors of mortality; Secondary Analyses
- Mixed-model involving the 12 predictors of mortality to evaluate potential hospital site effects;
- Logistic regression model looking at timing of irrigation and debridement and open fractures and deep infection rates;
- Descriptive analyses looking at types of treatments of tibia and femur fractures across socioeconomic groups in India;
- 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
- 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
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
30-day Mortality
Logistic regression including 12 a priori predictors of mortality.
Measured: 30 days post injury
Secondary outcomes (1)
Deep Infection
Logistic regression including 8 a priori predictors of deep infection in open fracture patients.
Measured: 30 days post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Principal investigator, Mohit Bhandari, McMaster University
- Investigators
- Mohit Bhandari, MD, PhD, Principal investigator, McMasterParag Sancheti, MD, Study director, Sancheti Institute for Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014974
- Sponsor's protocol ID
- INORMUSINDIA
- Acronym
- INORMUS
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2011
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15526049Stone 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.
PubMed 17296697Joshipura MK. Trauma care in India: current scenario. World J Surg. 2008 Aug;32(8):1613-7. doi: 10.1007/s00268-008-9634-5.
PubMed 18553048Joshipura 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.
PubMed 16736317Joshipura 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.
PubMed 12951294Mock 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.
PubMed 18679760Ma 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.
PubMed 18629598
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INORMUS 5,000: Large Observational Study of Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT02014974
- Acronym / sponsor ID
- INORMUS / INORMUSINDIA
- Conditions
- Bone Fractures
- Keywords
- Fractures, burden of fractures, orthopaedic fractures, orthopaedic injuries, orthopaedic trauma, fractures India, observational study, outcomes of fracture care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,822 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Logistic regression model involving 12 potential predictors of mortality; Secondary Analyses
- Mixed-model involving the 12 predictors of mortality to evaluate potential hospital site effects;
- Logistic regression model looking at timing of irrigation and debridement and open fractures and deep infection rates;
- Descriptive analyses looking at types of treatments of tibia and femur fractures across socioeconomic groups in India;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Public Hospitals | – | –Patients presenting and treated in public trauma centers in India. |
| Private Hospitals | – | –Patients presenting and treated in private trauma centers in India. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Over 17 years old;
- Diagnosis of orthopaedic fracture or dislocation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day Mortality
Time frame: 30 days post injury
Logistic regression including 12 a priori predictors of mortality.
1 secondary outcome
Deep Infection
Time frame: 30 days post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 15526049Rodgers 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.
- Background: PubMed 17296697Stone 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.
- Background: PubMed 18553048Joshipura MK. Trauma care in India: current scenario. World J Surg. 2008 Aug;32(8):1613-7. doi: 10.1007/s00268-008-9634-5.
- Background: PubMed 16736317Joshipura 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.
- Background: PubMed 12951294Joshipura 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.
- Background: PubMed 18679760Mock 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.
- Background: PubMed 18629598Ma 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.
- United Nations Global Road Traffic Safety CollaborationLink provided by the sponsor.
- Canadian Orthopaedic Association: Call for Action GroupLink provided by the sponsor.
- WHO's Make Roads Safe CampaignLink provided by the sponsor.
- McMaster University International Surgery DeskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Bhandari, MD, PhD principal investigator
McMaster
Parag Sancheti, MD study director
Sancheti Institute for Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fractures, run by McMaster University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Mortality (time frame: 30 days post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014974, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.