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TerminatedNCT02564133COL-FOPUpdated Aug 9, 2017

Hip Fracture and Patent Foramen Ovale

An interventional study of Transthoracic echocardiography in Hip Fractures, sponsored by Hopital Foch. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-09.

Sponsored by Hopital Foch · Not applicable, Interventional, and Diagnostic

Why this study was terminated
We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Hip Fractures

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03

In context

Hip Fractures

848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's enrollment of 41 is below the median of 90 across 540 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hip fracture requiring a surgical procedure

Exclusion criteria

Exclusion Criteria:

  • simultaneous other traumatic lesion
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    detection of a patent foramen ovale

    Device: Transthoracic echocardiography

Interventions

  • DeviceTransthoracic echocardiography

    A transthoracic echocardiography is performed to discover a patent foramen ovale

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What researchers measure

Primary outcomes

  1. Number of participants with postoperative complications probably related to the presence of a patent foramen ovale

    Complications probably related to the presence of a patent foramen ovale

    Time frame: First postoperative week

Secondary outcomes

  1. Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale

    Complications probably not related to the presence of a patent foramen ovale

    Time frame: First postoperative week

  2. Number of days before walking without help

    Time frame: One year

  3. Number of days at home during the first postoperative year

    Number of days of stay at home

    Time frame: one year

  4. Mortality

    Time frame: Three months and one year

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Study locations

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

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2015
First posted
Sep 30, 2015
Start
Jun 2013
Primary completionActual
Apr 26, 2017
CompletionActual
Apr 26, 2017
Last update
Aug 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02564133
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Jun 2013
Primary completion
Apr 26, 2017
Completion
Apr 26, 2017
Last update
Aug 9, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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