Trials / Completed
CompletedNCT02806063
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | intraoperative samples |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2016-06-20
- Last updated
- 2018-07-30
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02806063. Inclusion in this directory is not an endorsement.