Hip FractureNCT02279550
Institutional Registry of Hip Fracture in the Elderly
An observational study of Hip Fracture, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- How many people
- 2,000 participants
- Where
- 1 siteArgentina
- Study dates
- Nov 2016to Dec 2025
- How long will I take part?
- 20 Years
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: aged >65 hip fracture
Who may be able to join
- Patients over 65 with hip fracture.
- Admission to HIBA
- Followed by any health care provider. -
Who cannot join
- 1 Patient refuses to participate in the registration or informed consent process
- -
Trial locations and contacts
1 site in 1 country.
Javier A Benchimol, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1199
Diego H Giunta, MD, 54119590200 ext. 4419, diego.giunta@hospitalitaliano.org.ar
About this study
The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.
Read the detailed description
All patients over 65 years old who are admitted to the orthopedic and traumatology ward diagnosed with hip fracture will be assessed.
The generation of the list of potentially evaluable patients will be performed daily.
Once defined patient inclusion, an intern take oral informed consent and will proceed to complete the CRF.
Cohort will be followed at 3 months and a second follow-up at year.
Variables to be measured:
Patient Data Comorbidities Charlson score Scales functionality Factors prior to the fall Medications Trauma variables Complications Mortality
- Conditions
- Hip Fracture
- Keywords
- hip fracture, elderly
- Medical subject headings
- Hip Fractures
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 |
|---|---|---|
| hip fracture | aged >65 with hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 1 year
Secondary outcomes (1)
frailty (measured by the Rockwood Scale)
It will performed once included in the Register the Rockwood Scale of Frailty and year follow-up after.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies 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
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Alberto Benchimol, Hospital Italiano de Buenos Aires
- Investigators
- Javier A Benchimol, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279550
- Sponsor's protocol ID
- 1950
- Status last verified
- Mar 2024
- First submitted
- 16 Oct 2014
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolinsky FD, Fitzgerald JF, Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403. doi: 10.2105/ajph.87.3.398.
PubMed 9096540Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.
PubMed 11386929Alarcon Alarcon T, Gonzalez-Montalvo JI. [Osteoporotic hip fracture. Predictive factors of short-and long-term functional recovery]. An Med Interna. 2004 Feb;21(2):87-96. doi: 10.4321/s0212-71992004000200010. No abstract available. Spanish.
PubMed 14974897Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.
PubMed 19730176Riera-Espinoza G. Epidemiology of osteoporosis in Latin America 2008. Salud Publica Mex. 2009;51 Suppl 1:S52-5. doi: 10.1590/s0036-36342009000700009.
PubMed 19287895Benchimol J, Fiorentini F, Elizondo CM, Boietti BR, Carabelli G, Barla J, Sancineto C, Waisman GD, Giunta DH. Institutional Registry of Elderly Patients With Hip Fracture in a Community-Based Tertiary Care Hospital in Argentina (RIAFC). Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):121-5. doi: 10.1177/2151458516651309. Epub 2016 Jun 15.
PubMed 27551569
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Registry of Hip Fracture in the Elderly
- ClinicalTrials.gov ID
- NCT02279550
- Acronym / sponsor ID
- 1950
- Conditions
- Hip Fracture
- Keywords
- hip fracture, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Oct 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.
The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.
Detailed description
All patients over 65 years old who are admitted to the orthopedic and traumatology ward diagnosed with hip fracture will be assessed.
The generation of the list of potentially evaluable patients will be performed daily.
Once defined patient inclusion, an intern take oral informed consent and will proceed to complete the CRF.
Cohort will be followed at 3 months and a second follow-up at year.
Variables to be measured:
Patient Data Comorbidities Charlson score Scales functionality Factors prior to the fall Medications Trauma variables Complications Mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture | – | –aged >65 with hip fracture |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- aged >65 hip fracture
Key inclusion criteria (3 listed)
- Patients over 65 with hip fracture.
- Admission to HIBA
- Followed by any health care provider. -
Key exclusion criteria (2 listed)
- 1 Patient refuses to participate in the registration or informed consent process
- -
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
Time frame: 1 year
1 secondary outcome
frailty (measured by the Rockwood Scale)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 9096540Wolinsky FD, Fitzgerald JF, Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403. doi: 10.2105/ajph.87.3.398.
- Background: PubMed 11386929Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.
- Background: PubMed 14974897Alarcon Alarcon T, Gonzalez-Montalvo JI. [Osteoporotic hip fracture. Predictive factors of short-and long-term functional recovery]. An Med Interna. 2004 Feb;21(2):87-96. doi: 10.4321/s0212-71992004000200010. No abstract available. Spanish.
- Background: PubMed 19730176Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.
- Background: PubMed 19287895Riera-Espinoza G. Epidemiology of osteoporosis in Latin America 2008. Salud Publica Mex. 2009;51 Suppl 1:S52-5. doi: 10.1590/s0036-36342009000700009.
- Derived from this study: PubMed 27551569Benchimol J, Fiorentini F, Elizondo CM, Boietti BR, Carabelli G, Barla J, Sancineto C, Waisman GD, Giunta DH. Institutional Registry of Elderly Patients With Hip Fracture in a Community-Based Tertiary Care Hospital in Argentina (RIAFC). Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):121-5. doi: 10.1177/2151458516651309. Epub 2016 Jun 15.
- Individual participant dataSharing planned: No
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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.
Javier A Benchimol, MD contact
Javier A Benchimol, MD principal investigator
Hospital Italiano de Buenos Aires
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 Hip Fracture, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego H Giunta, MD (5411-9590200 ext. 4419, diego.giunta@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 year). 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 NCT02279550, which also lists 6 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 8 Mar 2024.