Latin America Hip Fracture Mortality Study (LAMOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01650064
First received: July 6, 2012
Last updated: July 14, 2015
Last verified: July 2015
  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: 200
Study Start Date: January 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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

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

Locations
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
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
Universidad de São Paulo
São Paulo, Brazil
Hospital Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Hospital São Paulo
São Paulo, Brazil
Hospital das Clinicas da UNICAMP
São Paulo, Brazil
Chile
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago, Chile
Hospital del Trabajador de Santiago
Santiago, Chile
Colombia
Hospital Infantil de San José
Bogotá, Colombia
Costa Rica
Hospital San Vicente de Paúl
San José, Costa Rica
Ecuador
Hospital Teodoro Maldonado Carbo
Guayaquil, Ecuador
Mexico
Hospital de Traumatología y Ortopedia "Lomas Verdes"
Ciudad de México, Mexico
Hospital de Traumatología y Ortopedia UMAE #21
Monterrey, Mexico
Uruguay
Asociación Española Primera de Socorros Mutuos
Montevideo, Uruguay
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: July 14, 2015
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2015