One-Stage Exchange for Chronically Infected Total Hip Arthroplasty

Infection Clinical Trial

Official title:

Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02825381
• Other study ID #: 2013-46
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: July 1, 2016
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Yves JENNY, MD
• Phone: 0388552145
• Email: jean-yves.jenny[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
France	CCOM, Hôpitaux Universitaires de Strasbourg	Illkirch	Bas Rhin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection of the prosthesis	Rate of diagnosis infection of the prosthesis	For the duration of hospital stay, up to 1 year]	Yes