Latin America Hip Fracture Mortality Study (LAMOS)

August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with surgically-treated hip fracture in Latin America

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: after 1 year
after 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score
Time Frame: Screening/Preoperative and 90 ± 21 days
Screening/Preoperative and 90 ± 21 days
Parker Mobility Score
Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Wound healing
Time Frame: 30±7 days, 60±14 days, and 90± 21 days
30±7 days, 60±14 days, and 90± 21 days
Fracture healing
Time Frame: 60±14 days and 90± 21 days
60±14 days and 90± 21 days
Anticipated surgical treatment-related adverse events
Time Frame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
EQ-5D
Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days
Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Investigators

  • Principal Investigator: Wiliam Belangero, Dr.med, Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAMOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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