Clinical trial NCT02806063: Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Official title: Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthetic Joint Infection
Keywords: Prosthesis
joint infection
perioperative samples
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
timeFrame: 18 months
Secondary outcomes:
measure: Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.
timeFrame: 18 months
measure: Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.
timeFrame: 18 months
measure: Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.
timeFrame: 18 months
measure: Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.
timeFrame: 18 months
measure: Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
state: Ile De France
Study officials:
affiliation: Groupe Hospitalier Diaconesses Croix Saint-Simon
name: Simon MARMOR, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: