Fractures or DislocationsINORMUSNCT02150980
INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)
An observational study of Fractures or Dislocations, run by McMaster University at 69 sites in 26 countries.
Trial summary
Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures or Dislocations
- How many people
- 39,797 participants
- Where
- 69 sitesin 26 countries
- Study dates
- Apr 2014to Nov 2023
- 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: All patients 18 years of age or older who are admitted to a recruiting hospital in low-middle income countries in Africa, Asia, and Latin America
Who may be able to join
- patients 18 years of age or older
- admitted to a recruiting hospital for treatment of an orthopaedic injury
- injury occurred within 3 months of hospital admission
- patients diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.
Who cannot join
None listed.
Trial locations and contacts
69 sites in 26 countries.
69 sites in 26 countries
China14 sites
Beijing Anzhen Hospital affiliated to Capital University of Medical Sciences
Beijing, Beijing Municipality
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
Beijing Luhe Hospital
Beijing, Beijing Municipality
Second Bethune Hospital of Jilin University
Changchun, Jilin
Hanzhong People's Hospital
Hanzhong, Shaanxi
Harbin Medical University Second hospital
Harbin, Heilongjiang
Anhui Provincial Hospital
Hefei, Anhui
Langfang Aidebao General Hospital
Langfang, Hebei
Langfang People's Hospital
Langfang, Hebei
Shanghai No.10 People's Hospital
Shanghai, Shanghai Municipality
Shenyang Orthopaedic Hospital
Shenyang, Liaoning
Tianjin Hospital
Tianjin, Tianjin Municipality
The 2nd affiliated hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xiamen University affiliated First Hospital
Xiamen, Fujian
India14 sites
St John Medical College
Bangalore
Post Graduate Institute of Medical Education and Research
Chandigarh
AIIMs Hospital
Delhi
Indian Institue for Spinal Care
Delhi
Smt N H L Municipal Medical College
Gujrāt, Ahmedabad
CMC Ludhiana
Ludhiana
Dr L H Hiranandani Hospital
Mumbai
Indira Ganghi Medical College
Puducherry
Medical College & Hospital, Bharati Vidyapeeth Deemed University
Pune
Noble Hospital
Pune
Sancheti Institute for Orthopaedics and Rehabilitation
Pune
Baptist Christian Hospital
Tezpur, Assam
CMC Vellore
Vellore
Data Meghe Institute of Medical Sciences
Wardha
Mexico6 sites
Hospital Civil de Guadalajara
Guadalajara
Social Security Hospitals
Guadalajara
Hospital Puerta de Hierro
Jalisco
Social Security Hospitals
Mexico City
Social Security Hospital
Monterrey
Christus Muguerza Hospital Saltillo
Saltillo
Kenya4 sites
Rift Valley provincial hospital
Karuru One
Kiambu District Hospital
Kiambu
AIC Kijabe Hospital
Kijabe
Kenyatta National Hospital
Nairobi
South Africa3 sites
Charlotte Maxete Johannesburg Acadamic Hospital
Johannesburg
Chris Hani Baragwanath Acadamic Hospital
Johannesburg
Helen Joseph Hospital
Johannesburg
Brazil2 sites
Hospital de Clínicas - UNICAMP
São José dos Campos
Hospital de Beneficencia Sirio-Libanes
São Paulo
Colombia2 sites
Centro Médico Imbanaco
Cali
Clinica Fracturas y Fracturas
Pereira
Nigeria2 sites
National Orthopaedic Hospital Enugu
Enugu
State trauma and surgical centre
Ondo
Tanzania2 sites
Muhimbili Orthopaedic Institute
Dar es Salaam
Kilimanjaro Christian Medical Centre
Moshi
Uganda2 sites
Fort Portal Regional Referral Hospital
Fort Portal
Mulago Hospital, Makerere University College of Health Sciences
Kampala
About this study
Official title: INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries.
Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.
Read the detailed description
Number of Participants:
40,000
Primary Research Objectives:
To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):
- The incidence of major complications (mortality, re-operation and infection) as a composite outcome and the components of the composite within 30 days post-hospital admission.
- The factors (system and patient variables) associated with the composite of major complications (mortality, re-operation and infection) within 30 days post-hospital admission.
Secondary Research Objective:
To determine the rates of major complications within 30 days post-hospital admission by type of fracture treatment provided (e.g. splinting versus operative fixation) and admission to hospital time (e.g. <72 hours or > 72 hours).
Diagnosis and Main Inclusion Criteria:
This study has minimal exclusion criteria by design. All patients 18 years of age or older admitted to a recruiting hospital for treatment of an orthopaedic injury that occurred within 3 months will be eligible for participation. Patients who are diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.
Study Outcomes:
The primary outcome is a composite of mortality, mortality, re-operation and infection within 30 days from hospital admission for all research objectives.
Duration of Patient Follow-Up:
Study participants will be followed until 30 days post hospital admission.
- Conditions
- Fractures or Dislocations
- Keywords
- Fractures, burden of fractures, orthopaedic fractures, orthopaedic injuries, orthopaedic trauma, observational study, outcomes of fracture care, epidemiology
- Medical subject headings
- Fractures, Bone, Joint Dislocations
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality, re-operation and infection
Measured: 30 days post-hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fractures or DislocationsStudies 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
- 39,797 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster Surgical Associates, National Health and Medical Research Council, Australia, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Mohit Bhandari, McMaster University
- Investigators
- Mohit Bhandari, MD, PhD, Principal investigator, McMaster UniversityPhilip Devereaux, MD, PhD, Principal investigator, McMaster UniversityRebecca Ivers, MPH, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150980
- Sponsor's protocol ID
- INORMUS_INTERNATIONAL
- Acronym
- INORMUS
- Status last verified
- Jun 2024
- First submitted
- 28 May 2014
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18679760Fitzharris M, Zhong W, Myburgh J, Xuezhong Y, Yu J, Hammond N, Finfer SR, Taylor C, Wu Y. The status of trauma registry systems in Chinese hospitals. Inj Prev. 2011 Dec;17(6):419-21. doi: 10.1136/injuryprev-2011-040216. Epub 2011 Oct 13.
PubMed 21998256Fitzharris M, Yu J, Hammond N, Taylor C, Wu Y, Finfer S, Myburgh J. Injury in China: a systematic review of injury surveillance studies conducted in Chinese hospital emergency departments. BMC Emerg Med. 2011 Oct 26;11:18. doi: 10.1186/1471-227X-11-18.
PubMed 22029774Bhalla K, Harrison JE, Shahraz S, Fingerhut LA; Global Burden of Disease Injury Expert Group. Availability and quality of cause-of-death data for estimating the global burden of injuries. Bull World Health Organ. 2010 Nov 1;88(11):831-838C. doi: 10.2471/BLT.09.068809. Epub 2010 Jun 22.
PubMed 21076564Foote CJ, Petrisor B, Beyene J, Devereaux PJ, Dhillon M, Sancheti P Kotwal P, Miclau T, Bhandari M, and the INORMUS Investigators. International Orthopaedic Multicenter Fracture Study (INORMUS). Paper presented at: Orthopaedic Trauma Association 2012 Annual Meeting; 2012 October 3-6; Minneapolis, Minnesota.
INORMUS Investigators. INternational ORthopaedic MUlticentre Study (INORMUS) in Fracture Care: Protocol for a Large Prospective Observational Study. J Orthop Trauma. 2015 Oct;29 Suppl 10:S2-6. doi: 10.1097/BOT.0000000000000404.
PubMed 26356208Foote CJ, Mundi R, Sancheti P, Gopalan H, Kotwal P, Shetty V, Dhillon M, Devereaux P, Thabane L, Aleem I, Ivers RQ, Bhandari M; INORMUS Investigators. Musculoskeletal trauma and all-cause mortality in India: a multicentre prospective cohort study. Lancet. 2015 Apr 27;385 Suppl 2:S30. doi: 10.1016/S0140-6736(15)60825-X. Epub 2015 Apr 26.
PubMed 26313078INORMUS Investigative Committee on behalf of all INORMUS Investigators. Operationalizing an orthopaedic research plan in the Decade of Action for Road Safety: the INternational ORthopaedic MUlticenter Study in Fracture Care. J Orthop Trauma. 2014;28 Suppl 1:S29. doi: 10.1097/BOT.0000000000000119. No abstract available.
PubMed 24857994Pouramin P, Li CS, Busse JW, Sprague S, Devereaux PJ, Jagnoor J, Ivers R, Bhandari M; INORMUS investigators. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study. Lancet Glob Health. 2020 May;8(5):e711-e720. doi: 10.1016/S2214-109X(20)30067-X.
PubMed 32353318
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INORMUS 40,000: Large Observational Cohort Study of Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT02150980
- Acronym / sponsor ID
- INORMUS / INORMUS_INTERNATIONAL
- Conditions
- Fractures or Dislocations
- Keywords
- Fractures, burden of fractures, orthopaedic fractures, orthopaedic injuries, orthopaedic trauma, observational study, outcomes of fracture care, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,797 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), McMaster Surgical Associates, National Health and Medical Research Council, Australia, Hamilton Health Sciences Corporation
- Study start
- Apr 2014
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 30 May 2014 (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 represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries.
Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.
Detailed description
Number of Participants:
40,000
Primary Research Objectives:
To determine among adult individuals admitted to hospital with musculoskeletal trauma (e.g. fractures or dislocations):
- The incidence of major complications (mortality, re-operation and infection) as a composite outcome and the components of the composite within 30 days post-hospital admission.
- The factors (system and patient variables) associated with the composite of major complications (mortality, re-operation and infection) within 30 days post-hospital admission.
Secondary Research Objective:
To determine the rates of major complications within 30 days post-hospital admission by type of fracture treatment provided (e.g. splinting versus operative fixation) and admission to hospital time (e.g. <72 hours or > 72 hours).
Diagnosis and Main Inclusion Criteria:
This study has minimal exclusion criteria by design. All patients 18 years of age or older admitted to a recruiting hospital for treatment of an orthopaedic injury that occurred within 3 months will be eligible for participation. Patients who are diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.
Study Outcomes:
The primary outcome is a composite of mortality, mortality, re-operation and infection within 30 days from hospital admission for all research objectives.
Duration of Patient Follow-Up:
Study participants will be followed until 30 days post hospital admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years of age or older who are admitted to a recruiting hospital in low-middle income countries in Africa, Asia, and Latin America
Key inclusion criteria (4 listed)
- patients 18 years of age or older
- admitted to a recruiting hospital for treatment of an orthopaedic injury
- injury occurred within 3 months of hospital admission
- patients diagnosed with an orthopaedic fracture, dislocation, or fracture dislocation of the appendicular skeleton or spine will be included.
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
mortality, re-operation and infection
Time frame: 30 days post-hospital admission
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 6 Jun 2024.
- 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 21998256Fitzharris M, Zhong W, Myburgh J, Xuezhong Y, Yu J, Hammond N, Finfer SR, Taylor C, Wu Y. The status of trauma registry systems in Chinese hospitals. Inj Prev. 2011 Dec;17(6):419-21. doi: 10.1136/injuryprev-2011-040216. Epub 2011 Oct 13.
- Background: PubMed 22029774Fitzharris M, Yu J, Hammond N, Taylor C, Wu Y, Finfer S, Myburgh J. Injury in China: a systematic review of injury surveillance studies conducted in Chinese hospital emergency departments. BMC Emerg Med. 2011 Oct 26;11:18. doi: 10.1186/1471-227X-11-18.
- Background: PubMed 21076564Bhalla K, Harrison JE, Shahraz S, Fingerhut LA; Global Burden of Disease Injury Expert Group. Availability and quality of cause-of-death data for estimating the global burden of injuries. Bull World Health Organ. 2010 Nov 1;88(11):831-838C. doi: 10.2471/BLT.09.068809. Epub 2010 Jun 22.
- BackgroundFoote CJ, Petrisor B, Beyene J, Devereaux PJ, Dhillon M, Sancheti P Kotwal P, Miclau T, Bhandari M, and the INORMUS Investigators. International Orthopaedic Multicenter Fracture Study (INORMUS). Paper presented at: Orthopaedic Trauma Association 2012 Annual Meeting; 2012 October 3-6; Minneapolis, Minnesota.
- Background: PubMed 26356208INORMUS Investigators. INternational ORthopaedic MUlticentre Study (INORMUS) in Fracture Care: Protocol for a Large Prospective Observational Study. J Orthop Trauma. 2015 Oct;29 Suppl 10:S2-6. doi: 10.1097/BOT.0000000000000404.
- Background: PubMed 26313078Foote CJ, Mundi R, Sancheti P, Gopalan H, Kotwal P, Shetty V, Dhillon M, Devereaux P, Thabane L, Aleem I, Ivers RQ, Bhandari M; INORMUS Investigators. Musculoskeletal trauma and all-cause mortality in India: a multicentre prospective cohort study. Lancet. 2015 Apr 27;385 Suppl 2:S30. doi: 10.1016/S0140-6736(15)60825-X. Epub 2015 Apr 26.
- Background: PubMed 24857994INORMUS Investigative Committee on behalf of all INORMUS Investigators. Operationalizing an orthopaedic research plan in the Decade of Action for Road Safety: the INternational ORthopaedic MUlticenter Study in Fracture Care. J Orthop Trauma. 2014;28 Suppl 1:S29. doi: 10.1097/BOT.0000000000000119. No abstract available.
- Derived from this study: PubMed 32353318Pouramin P, Li CS, Busse JW, Sprague S, Devereaux PJ, Jagnoor J, Ivers R, Bhandari M; INORMUS investigators. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study. Lancet Glob Health. 2020 May;8(5):e711-e720. doi: 10.1016/S2214-109X(20)30067-X.
- 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.
Related trials for Fractures or Dislocations
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Recruiting
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
Elbow Pain, Supracondylar Humerus Fracture
Enrolling by invitation
G7 Dual Mobility With Vivacit-E or Longevity PMCF
Hip Osteoarthritis, Rheumatoid Arthritis
Active, not recruiting
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Osteoarthritis, Arthritis
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 University
Philip Devereaux, MD, PhD principal investigator
McMaster University
Rebecca Ivers, MPH, PhD principal investigator
The George Institute
69 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures or Dislocations, run by McMaster University at 69 sites in 26 countries.
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 4 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in China, India, Mexico, Kenya, South Africa and 21 more countries. 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?
mortality, re-operation and infection (time frame: 30 days post-hospital admission). 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 NCT02150980, which also lists 9 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 6 Jun 2024.