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

NCT02806063 | Completed DMC

• 1 other identifier: ID RCB : 2015-A01698-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthetic Joint Infection

Keywords

Prosthesis; joint infection; perioperative samples

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.

  18 months

• Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.

  18 months

• Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.

  18 months

• Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.

  18 months

• Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.

  18 months

Study Arms (1)

Intraoperative samples

OTHER

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.

Procedure: intraoperative samples

Interventions

intraoperative samples PROCEDURE

Intraoperative samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

Location

Study Officials

• Simon MARMOR, Doctorate

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 20, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)