Latin America Hip Fracture Mortality Study (LAMOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01650064
First received: July 6, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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


Condition
Hip Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Latin America Hip Fracture Mortality Study

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Death [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Screening/Preoperative and 90 ± 21 days ] [ Designated as safety issue: No ]
  • Parker Mobility Score [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days ] [ Designated as safety issue: No ]
  • Wound healing [ Time Frame: 30±7 days, 60±14 days, and 90± 21 days ] [ Designated as safety issue: No ]
  • Fracture healing [ Time Frame: 60±14 days and 90± 21 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with surgically-treated hip fracture in Latin America

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650064

Contacts
Contact: Shandher Tovar, Dr.med +51 997 511 008 shandher.tovar@aofoundation.org
Contact: Denise Schmid +41 44 200 2477 denise.schmid@aofoundation.org

Locations
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina
Contact: Jorge Barla, MD         
Principal Investigator: Jorge Barla, MD         
Brazil
Hospital Vila Velha Not yet recruiting
Espirito Santo, Brazil
Contact: Jose E Grandi Ribeiro Filho, MD         
Principal Investigator: Jose E Grandi Ribeiro Filho, MD         
IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo Not yet recruiting
Passo Fundo, Brazil
Contact: Luiz H Penteado da Silva, MD         
Principal Investigator: Luiz H Penteado da Silva, MD         
Hospital Municipal Miguel Couto Not yet recruiting
Rio de Janeiro, Brazil
Contact: Vincenzo Giordano, MD         
Principal Investigator: Vincenzo Giordano, MD         
Hospital São Paulo Not yet recruiting
São Paulo, Brazil
Contact: Helio J Alvachian Fernandes, MD         
Principal Investigator: Helio J Alvachian Fernandes, MD         
Universidad de São Paulo Not yet recruiting
São Paulo, Brazil
Contact: Kodi E Kojima, MD         
Principal Investigator: Kodi E Kojima, MD         
Hospital Irmandade da Santa Casa de Misericórdia de São Paulo Not yet recruiting
São Paulo, Brazil
Contact: Ralph W Christian, MD         
Principal Investigator: Ralph W Christian, MD         
Hospital das Clinicas da UNICAMP Not yet recruiting
São Paulo, Brazil
Contact: William Belangero, MD         
Principal Investigator: William Belangero, MD         
Chile
Hospital del Trabajador de Santiago Not yet recruiting
Santiago, Chile
Contact: Alejandro D Zylberberg Serman, MD         
Principal Investigator: Alejandro D Zylberberg Serman, MD         
Hospital Clínico Pontificia Universidad Católica de Chile Not yet recruiting
Santiago, Chile
Contact: Daniel A Schweitzer Fernández, MD         
Principal Investigator: Daniel A Schweitzer Fernández, MD         
Colombia
Hospital Infantil de San José Not yet recruiting
Bogotá, Colombia
Contact: Carlos M Olarte Salazar, MD         
Principal Investigator: Carlos M Olarte Salazar, MD         
Costa Rica
Hospital San Vicente de Paúl Not yet recruiting
San José, Costa Rica
Contact: Kenneth Barquero Blackshaw, MD         
Principal Investigator: Kenneth Barquero Blackshaw, MD         
Ecuador
Hospital Teodoro Maldonado Carbo Not yet recruiting
Guayaquil, Ecuador
Contact: Miguel A Mite Vivar, MD         
Principal Investigator: Miguel A Mite Vivar, MD         
Mexico
Hospital de Traumatología y Ortopedia "Lomas Verdes" Not yet recruiting
Ciudad de México, Mexico
Contact: Sergio A Oliva Ramirez, MD         
Principal Investigator: Sergio A Oliva Ramirez, MD         
Hospital de Traumatología y Ortopedia UMAE #21 Not yet recruiting
Monterrey, Mexico
Contact: José R Mendoza de la Cruz, MD         
Principal Investigator: José R Mendoza de la Cruz, MD         
Uruguay
Asociación Española Primera de Socorros Mutuos Recruiting
Montevideo, Uruguay
Contact: Daniel H Rienzi Bergalli, MD         
Principal Investigator: Daniel H Rienzi Bergalli, MD         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Wiliam Belangero, Dr.med Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01650064     History of Changes
Other Study ID Numbers: LAMOS
Study First Received: July 6, 2012
Last Updated: March 25, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation:
Hip fracture
Mortality

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 01, 2014