Hip Fracture and Patent Foramen Ovale (COL-FOP)

August 8, 2017 updated by: Hopital Foch

Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?

Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.

A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.

The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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
      • Levallois-Perret, France, 92300
        • Institut Hospitalier Franco-Britannique
      • Rennes, France, 35000
        • CHU

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hip fracture requiring a surgical procedure

Exclusion Criteria:

  • simultaneous other traumatic lesion

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: detection of a patent foramen ovale
Device: Transthoracic echocardiography
A transthoracic echocardiography is performed to discover a patent foramen ovale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale
Time Frame: First postoperative week
Complications probably related to the presence of a patent foramen ovale
First postoperative week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale
Time Frame: First postoperative week
Complications probably not related to the presence of a patent foramen ovale
First postoperative week
Number of days before walking without help
Time Frame: One year
One year
Number of days at home during the first postoperative year
Time Frame: one year
Number of days of stay at home
one year
Mortality
Time Frame: Three months and one year
Three months and one year

Collaborators and Investigators

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

Sponsor

Hopital Foch

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

June 1, 2013

Primary Completion (ACTUAL)

April 26, 2017

Study Completion (ACTUAL)

April 26, 2017

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (ESTIMATE)

September 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/35
  • 2012-A01155-38 (OTHER: ANSM)

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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