Prosthetic Joint InfectionBac-UPNCT02806063
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
A study testing intraoperative samples in people with Prosthetic Joint Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- intraoperative samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, 75020
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Prosthetic Joint Infection
- Being tested
- intraoperative samples
- Keywords
- Prosthesis, joint infection, perioperative samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intraoperative samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Simon MARMOR, Doctorate, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806063
- Sponsor's protocol ID
- ID RCB : 2015-A01698-41
- Acronym
- Bac-UP
- Status last verified
- Jul 2018
- First submitted
- 25 May 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT02806063
- Acronym / sponsor ID
- Bac-UP / ID RCB : 2015-A01698-41
- Conditions
- Prosthetic Joint Infection
- Keywords
- Prosthesis, joint infection, perioperative samples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative samples | Other | Procedure: intraoperative samplesDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative samples | Procedure or surgery | Intraoperative samples |
Primary outcome
The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
Time frame: 18 months
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.
5 secondary outcomes
Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.
Time frame: 18 months
Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.
Time frame: 18 months
Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.
Time frame: 18 months
Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.
Time frame: 18 months
Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon MARMOR, Doctorate principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative samples in people with Prosthetic Joint Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.