Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection (Bac-UP)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Status: Completed

Conditions: Prosthetic Joint Infection

Treatments: Procedure: intraoperative samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02806063

ID RCB : 2015-A01698-41

Details and patient eligibility

About

Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately.

One stage and two stage exchange surgery both are the conventional surgical procedures for chronic PJI commonly used to date.

Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. However one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated.

Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty.

The total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic PJI.

Full description

Study duration: Two weeks. Recruitment period: 18 months. Maximal duration of data collection: Two weeks. Investigator center: monocenter study. Mean patient inclusion per year: 70 patients per year.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient consent
• Aged over 18 years
• PJI documented preoperatively by joint fluid culture according to Musculoskeletal Infection Society Definition
• Monoarticular PJI
• PJI management validated at the weekly cross-disciplinary conciliation meeting
• PJI treated with one stage surgery and intravenous antibiotherapy adjusted to preoperative aspiration results.

Exclusion criteria

• patient who does not meet eligibility criteria
• Negative preoperative aspiration culture
• PJI du to fungi
• Patient lawfully deprived of his liberty
• Patient insured under social security scheme

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Intraoperative samples

Other group

Description:

During this study of health care procedure evaluating microbiological setting in PJI prior prosthesis implantation with one stage surgery, 3 additional perioperative samples will be performed prior prosthesis implantation for every patient.

Treatment:

Procedure: intraoperative samples