One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

Prosthetic Joint Infection Clinical Trial

Official title:

One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473392
• Other study ID #: 69HCL18_0237
• Status: Completed
• First received: March 15, 2018
• Last updated: March 15, 2018
• Start date: April 2016
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• > 18 years old

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Exchange of Prosthetic Joint
• Infection
• One-step Exchange
• Prosthetic Joint Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial epidemiology	This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.	at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary	Treatment failure	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)