Latin America Hip Fracture Mortality Study

Hip Fractures Clinical Trial

— LAMOS  

Official title:

Latin America Hip Fracture Mortality Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650064
• Other study ID #: LAMOS
• Status: Completed
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Brazil	Hospital Vila Velha	Espirito Santo
Brazil	IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo	Passo Fundo
Brazil	Hospital Municipal Miguel Couto	Rio de Janeiro
Brazil	Hospital das Clinicas da UNICAMP	São Paulo
Brazil	Hospital Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo
Brazil	Hospital São Paulo	São Paulo
Brazil	Universidad de São Paulo	São Paulo
Chile	Hospital Clínico Pontificia Universidad Católica de Chile	Santiago
Chile	Hospital del Trabajador de Santiago	Santiago
Colombia	Hospital Infantil de San José	Bogotá
Costa Rica	Hospital San Vicente de Paúl	San José
Ecuador	Hospital Teodoro Maldonado Carbo	Guayaquil
Mexico	Hospital de Traumatología y Ortopedia "Lomas Verdes"	Ciudad de México
Mexico	Hospital de Traumatología y Ortopedia UMAE #21	Monterrey
Uruguay	Asociación Española Primera de Socorros Mutuos	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Costa Rica,  Ecuador,  Mexico,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		after 1 year
Secondary	Harris Hip Score		Screening/Preoperative and 90 ± 21 days
Secondary	Parker Mobility Score		Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Secondary	Wound healing		30±7 days, 60±14 days, and 90± 21 days
Secondary	Fracture healing		60±14 days and 90± 21 days
Secondary	Anticipated surgical treatment-related adverse events		Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
Secondary	EQ-5D		Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days