Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection (Bac-UP)
27 juli 2018 uppdaterad av: SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ile De France
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Paris, Ile De France, Frankrike, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Intraoperative samples
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
Tidsram: 18 months
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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.
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18 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.
Tidsram: 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.
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18 months
|
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Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.
Tidsram: 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.
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18 months
|
|
Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.
Tidsram: 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.
|
18 months
|
|
Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.
Tidsram: 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.
|
18 months
|
|
Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.
Tidsram: 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.
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18 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Simon MARMOR, Doctorate, Groupe Hospitalier Diaconesses Croix Saint-Simon
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2016
Primärt slutförande (Faktisk)
1 juni 2018
Avslutad studie (Faktisk)
1 juni 2018
Studieregistreringsdatum
Först inskickad
25 maj 2016
Först inskickad som uppfyllde QC-kriterierna
17 juni 2016
Första postat (Uppskatta)
20 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ID RCB : 2015-A01698-41
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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