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NCT02564133 Clinical Trial

Hip Fracture and Patent Foramen Ovale

Hip Fractures Clinical Trial

— COL-FOP  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02564133
Other study ID # 2012/35
Secondary ID 2012-A01155-38
Status Terminated
Phase N/A
First received September 29, 2015
Last updated August 8, 2017
Start date June 2013
Est. completion date April 26, 2017

Study information
Verified date August 2017
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 41
Est. completion date April 26, 2017
Est. primary completion date April 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- hip fracture requiring a surgical procedure

Exclusion Criteria:

- simultaneous other traumatic lesion

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transthoracic echocardiography
A transthoracic echocardiography is performed to discover a patent foramen ovale

Locations
Country Name City State
France Institut Hospitalier Franco-Britannique Levallois-Perret
France CHU Rennes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 First postoperative week
Secondary 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 First postoperative week
Secondary Number of days before walking without help One year
Secondary Number of days at home during the first postoperative year Number of days of stay at home one year
Secondary Mortality Three months and one year
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Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
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