Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection

Prosthetic Joint Infection Clinical Trial

— Bac-UP  

Official title:

Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806063
• Other study ID #: ID RCB : 2015-A01698-41
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Prosthetic Joint Infection

Intervention

Procedure:
• intraoperative samples

Locations

Country	Name	City	State
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months
Secondary	Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months
Secondary	Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months
Secondary	Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months
Secondary	Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months
Secondary	Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.	In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism. For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.	18 months