Hip Fracture and Patent Foramen Ovale

Not Applicable

Terminated

• Conditions: Hip Fractures
• Interventions: Device: Transthoracic echocardiography

• Registration Number: NCT02564133
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Primary Completion: 2017-04-26
• Study Completion: 2017-04-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• hip fracture requiring a surgical procedure

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Exclusion Criteria

• simultaneous other traumatic lesion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
detection of a patent foramen ovale	Transthoracic echocardiography	-

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale	First postoperative week	Complications probably related to the presence of a patent foramen ovale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Institut Hospitalier Franco-Britannique; 🇫🇷 Levallois-Perret, France

CHU; 🇫🇷 Rennes, France