Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 47 for:    "Prosthetic Joint Infection"

Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection (Bac-UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02806063
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon

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.


Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Procedure: intraoperative samples Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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.
Procedure: intraoperative samples



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806063


Locations
Layout table for location information
France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Ile De France, France, 75020
Sponsors and Collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
Investigators
Layout table for investigator information
Principal Investigator: Simon MARMOR, Doctorate Groupe Hospitalier Diaconesses Croix Saint-Simon

Layout table for additonal information
Responsible Party: SMARMOR, Orthopaedic surgeon, Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT02806063     History of Changes
Other Study ID Numbers: ID RCB : 2015-A01698-41
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon:
Prosthesis
joint infection
perioperative samples

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases