Clinical Trial: Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
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 Summary: 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.
Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Groupe Hospitalier Diaconesses Croix Saint-Simon
Dates:
Date Received: May 25, 2016
Date Started: April 2016
Date Completion: February 2018
Last Updated: June 17, 2016
Last Verified: June 2016