Clinical trial NCT01650064: Latin America Hip Fracture Mortality Study
Official title: Latin America Hip Fracture Mortality Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: Hip fracture
Mortality
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 168
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgically-treated hip fracture in Latin America

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Death
timeFrame: after 1 year
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Screening/Preoperative and 90 ± 21 days
measure: Parker Mobility Score
timeFrame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
measure: Wound healing
timeFrame: 30±7 days, 60±14 days, and 90± 21 days
measure: Fracture healing
timeFrame: 60±14 days and 90± 21 days
measure: Anticipated surgical treatment-related adverse events
timeFrame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
measure: EQ-5D
timeFrame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Espirito Santo
country: Brazil
facility: Hospital Vila Velha
city: Passo Fundo
country: Brazil
facility: IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo
city: Rio de Janeiro
country: Brazil
facility: Hospital Municipal Miguel Couto
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da UNICAMP
city: São Paulo
country: Brazil
facility: Hospital Irmandade da Santa Casa de Misericórdia de São Paulo
city: São Paulo
country: Brazil
facility: Hospital São Paulo
city: São Paulo
country: Brazil
facility: Universidad de São Paulo
city: Santiago
country: Chile
facility: Hospital Clínico Pontificia Universidad Católica de Chile
city: Santiago
country: Chile
facility: Hospital del Trabajador de Santiago
city: Bogotá
country: Colombia
facility: Hospital Infantil de San José
city: San José
country: Costa Rica
facility: Hospital San Vicente de Paúl
city: Guayaquil
country: Ecuador
facility: Hospital Teodoro Maldonado Carbo
city: Ciudad de México
country: Mexico
facility: Hospital de Traumatología y Ortopedia "Lomas Verdes"
city: Monterrey
country: Mexico
facility: Hospital de Traumatología y Ortopedia UMAE #21
city: Montevideo
country: Uruguay
facility: Asociación Española Primera de Socorros Mutuos
Study officials:
affiliation: Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil
name: Wiliam Belangero, Dr.med
role: PRINCIPAL_INVESTIGATOR
References: