Hip FracturesLAMOSNCT01650064
Latin America Hip Fracture Mortality Study
An observational study of Hip Fractures, run by AO Clinical Investigation and Publishing Documentation at 16 sites in 8 countries.
Trial summary
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Hip Fractures
- How many people
- 168 participants
- Where
- 16 sitesin 8 countries
- Study dates
- Jan 2013to Dec 2016
- 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 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with surgically-treated hip fracture in Latin America
Who may be able to join
- Adults 60 years and older
- Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation
- Primary surgical fracture treatment within 10 days after trauma
- No prior treatment for the fracture
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the clinical investigation according to the CIP
- Signed and dated IRB/EC-approved written informed consent
Who cannot join
- Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)
- Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
- Active malignancy
- Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)
- Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
Show all 10Show fewer
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Noncompletion of patient baseline questionnaires
- Prior implant on the fractured hip
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
Brazil7 sites
Hospital Vila Velha
Espírito Santo
IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo
Passo Fundo
Hospital Municipal Miguel Couto
Rio de Janeiro
Hospital das Clinicas da UNICAMP
São Paulo
Hospital Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo
Hospital São Paulo
São Paulo
Universidad de São Paulo
São Paulo
Chile2 sites
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago
Hospital del Trabajador de Santiago
Santiago
Mexico2 sites
Hospital de Traumatología y Ortopedia "Lomas Verdes"
Mexico City
Hospital de Traumatología y Ortopedia UMAE #21
Monterrey
About this study
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.
Read the detailed description
This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.
- Conditions
- Hip Fractures
- Keywords
- Hip fracture, Mortality
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: after 1 year
Secondary outcomes (6)
Harris Hip Score
Measured: Screening/Preoperative and 90 ± 21 days
Parker Mobility Score
Measured: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Wound healing
Measured: 30±7 days, 60±14 days, and 90± 21 days
Fracture healing
Measured: 60±14 days and 90± 21 days
Anticipated surgical treatment-related adverse events
Measured: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
EQ-5D
Measured: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wiliam Belangero, Dr.med, Principal investigator, Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650064
- Sponsor's protocol ID
- LAMOS
- Acronym
- LAMOS
- Status last verified
- Jan 2017
- First submitted
- 6 Jul 2012
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latin America Hip Fracture Mortality Study
- ClinicalTrials.gov ID
- NCT01650064
- Acronym / sponsor ID
- LAMOS / LAMOS
- Conditions
- Hip Fractures
- Keywords
- Hip fracture, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jul 2012 (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.
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.
Detailed description
This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with surgically-treated hip fracture in Latin America
Key inclusion criteria (7 listed)
- Adults 60 years and older
- Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation
- Primary surgical fracture treatment within 10 days after trauma
- No prior treatment for the fracture
- Ability to understand the content of the patient information / informed consent form
Key exclusion criteria (10 listed)
- Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)
- Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
- Active malignancy
- Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)
- Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)
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
Death
Time frame: after 1 year
6 secondary outcomes
Harris Hip Score
Time frame: Screening/Preoperative and 90 ± 21 days
Parker Mobility Score
Time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Wound healing
Time frame: 30±7 days, 60±14 days, and 90± 21 days
Fracture healing
Time frame: 60±14 days and 90± 21 days
Anticipated surgical treatment-related adverse events
Time frame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
EQ-5D
Time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
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 13 Aug 2020.
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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.
Wiliam Belangero, Dr.med principal investigator
Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by AO Clinical Investigation and Publishing Documentation at 16 sites in 8 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 7 inclusion and 10 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Brazil, Chile, Mexico, Argentina, Colombia and 3 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?
Death (time frame: after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2020.