Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

One-Stage Exchange for Chronically Infected Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825381
Recruitment Status : Unknown
Verified January 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.

The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure


Condition or disease
Infection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty
Study Start Date : July 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017



Primary Outcome Measures :
  1. infection of the prosthesis [ Time Frame: For the duration of hospital stay, up to 1 year] ]
    Rate of diagnosis infection of the prosthesis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cases operated on at the investigators institution between January 1, 2007 and November 30, 2010
Criteria

Inclusion Criteria:

  • Chronically infected total hip Arthroplasty
  • One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010

Exclusion Criteria:

  • Patient refused to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825381


Contacts
Layout table for location contacts
Contact: Jean-Yves JENNY, MD 0388552145 jean-yves.jenny@chru-strasbourg.fr

Locations
Layout table for location information
France
CCOM, Hôpitaux Universitaires de Strasbourg
Illkirch, Bas Rhin, France, 67400
Principal Investigator: Jean-Yves JENNY, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02825381    
Other Study ID Numbers: 2013-46
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Strasbourg, France:
Arthroplasty
Hip