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NCT Number: NCT02806063

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

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.

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Key information

Conditions

Prosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraoperative samples

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.

    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.

  2. Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.

    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.

  3. Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.

    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.

  4. Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.

    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. Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.

    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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Acronym: Bac-UP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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