NCT02014974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,822

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 27, 2011

Last Update Submit

September 29, 2017

Conditions

Bone Fractures

Keywords

Fracturesburden of fracturesorthopaedic fracturesorthopaedic injuriesorthopaedic traumafractures Indiaobservational studyoutcomes of fracture carewait times Indiaepidemiology

Outcome Measures

Primary Outcomes (1)

  • 30-day Mortality

    Logistic regression including 12 a priori predictors of mortality.

    30 days post injury

Secondary Outcomes (1)

  • Deep Infection

    30 days post-injury

Study Arms (2)

Public Hospitals

Patients presenting and treated in public trauma centers in India.

Private Hospitals

Patients presenting and treated in private trauma centers in India.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancheti Institute of Orthopaedics

Pune, Maharashtra, 411005, India

Location

Related Publications (7)

  • 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.

    PMID: 15526049BACKGROUND

  • 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.

    PMID: 17296697BACKGROUND

  • Joshipura MK. Trauma care in India: current scenario. World J Surg. 2008 Aug;32(8):1613-7. doi: 10.1007/s00268-008-9634-5.

    PMID: 18553048BACKGROUND

  • 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.

    PMID: 16736317BACKGROUND

  • 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.

    PMID: 12951294BACKGROUND

  • 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.

    PMID: 18679760BACKGROUND

  • 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.

    PMID: 18629598BACKGROUND

Related Links

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Mohit Bhandari, MD, PhD

    McMaster

    PRINCIPAL INVESTIGATOR

  • Parag Sancheti, MD

    Sancheti Institute for Orthopaedics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Chair of Division of Orthopaedics

Study Record Dates

First Submitted

September 27, 2011

First Posted

December 19, 2013

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

IN(1)