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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02279550
Other study ID # 1950
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2025

Study information

Verified date March 2024
Source Hospital Italiano de Buenos Aires
Contact Diego H Giunta, MD
Phone 5411-9590200
Email diego.giunta@hospitalitaliano.org.ar
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Patients over 65 with hip fracture. 2. Admission to HIBA 3. Followed by any health care provider. - Exclusion Criteria: 1 Patient refuses to participate in the registration or informed consent process -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aires Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

Alarcon 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. — View Citation

Hannan 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. — View Citation

Riera-Espinoza G. Epidemiology of osteoporosis in Latin America 2008. Salud Publica Mex. 2009;51 Suppl 1:S52-5. doi: 10.1590/s0036-36342009000700009. — View Citation

Robinson 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary mortality 1 year
Secondary frailty (measured by the Rockwood Scale) It will performed once included in the Register the Rockwood Scale of Frailty and year follow-up after. 1 year
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