Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection (Bac-UP)
Primary Purpose
Prosthetic Joint Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intraoperative samples
Sponsored by
About this trial
This is an interventional health services research trial for Prosthetic Joint Infection focused on measuring Prosthesis, joint infection, perioperative samples
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier Diaconesses Croix Saint Simon
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intraoperative samples
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02806063
First Posted
May 25, 2016
Last Updated
July 27, 2018
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
1. Study Identification
Unique Protocol Identification Number
NCT02806063
Brief Title
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Acronym
Bac-UP
Official Title
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
Keywords
Prosthesis, joint infection, perioperative samples
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative samples
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
intraoperative samples
Primary Outcome Measure Information:
Title
The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.
Description
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.
Time Frame
18 months
Title
Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.
Description
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.
Time Frame
18 months
Title
Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.
Description
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.
Time Frame
18 months
Title
Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.
Description
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.
Time Frame
18 months
Title
Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon MARMOR, Doctorate
Organizational Affiliation
Groupe Hospitalier Diaconesses Croix Saint-Simon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
We'll reach out to this number within 24 hrs