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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prosthetic Joint Infection

Intervention / Treatment
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* Procedure: intraoperative samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intraoperative samples<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthesis, joint infection, perioperative samples