Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens (FESF-Amiens)

July 17, 2020 updated by: Centre Hospitalier Universitaire, Amiens

Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.

In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.

The reduction of the incidence of post-operative complications includes the identification of risk factors.

No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

310

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

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients operated with an EFSF and meeting the inclusion criteria

Description

Inclusion Criteria:

  • All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens
  • Patients transferred to the CHU after being cared for in another structure will be included.
  • If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized

Exclusion Criteria:

  • Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)
  • Fractures of the upper end of the femur associated with polytrauma will not be included.

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
Mortality at 6 months of EFSF patients
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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 (Actual)

June 2, 2016

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI2016-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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