Skip to main content
OpenTrials
Completed

NCT Number: NCT01650064

Latin America Hip Fracture Mortality Study

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: after 1 year

Secondary outcomes

  1. Harris Hip Score

    Time frame: Screening/Preoperative and 90 ± 21 days

  2. Parker Mobility Score

    Time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days

  3. Wound healing

    Time frame: 30±7 days, 60±14 days, and 90± 21 days

  4. Fracture healing

    Time frame: 60±14 days and 90± 21 days

  5. 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

  6. EQ-5D

    Time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Acronym: LAMOS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2012
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.