Latin America Hip Fracture Mortality Study

CompletadoClinicalTrials.gov

ID: NCT01650064Tipo: OBSERVATIONALInicio: 1 de ene de 2013Fin estimado: 1 de dic de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

Descripción detallada

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.

Elegibilidad

Edad mínima: 60 YearsEdad máxima: 110 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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
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

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Patrocinadores

PrincipalAO Clinical Investigation and Publishing Documentation

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Latin America Hip Fracture Mortality Study | EligiMed