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Clinical Trials/NCT02564133
NCT02564133TerminatedNot Applicable

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

Hopital Foch4 sites in 1 country41 target enrollmentStarted: June 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
41
Locations
4
Primary Endpoint
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • hip fracture requiring a surgical procedure

Exclusion Criteria

  • simultaneous other traumatic lesion

Arms & Interventions

detection of a patent foramen ovale

Experimental

Intervention: Transthoracic echocardiography (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Number of days at home during the first postoperative year(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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