Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02413034
Eligibility Criteria:
Inclusion Criteria: as defined previously
* All the patients diagnosed with PJI who meet Zimmerli criteria and undergo a first-stage exchange, or débridment and retention procedure, in case there is an acute infection. These criteria are: visible sinus tract or purulence surrounding the prosthesis; detection of an infecting microorganism in the synovial fluid aspiration samples, intraoperative tissue and/or fluid cultures; synovial white blood cell count and histopathology parameters. The investigators will also include an additional criterion, which is prosthetic loosening 2 years after primary arthroplasty implantation following recent Portillo findings.
* The investigators will include hip, knee and shoulder replacements.
Exclusion Criteria:
* Patients receiving any kind of antibiotic regimen during the previous week of surgery;
* Hemodynamically unstable patients in need of antibiotic therapy, previously to the surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02413034
Study Brief:
Protocol Section:
NCT02413034