One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

Completed

• Conditions: Prosthetic Joint Infection; One-step Exchange; Exchange of Prosthetic Joint

• Registration Number: NCT03473392
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..

A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.

The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
• > 18 years old

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bacterial epidemiology	at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)	This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.

Secondary Outcome Measures

Name	Time	Method
Treatment failure	at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin