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:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT02372435
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged ≥18 years with hip, knee or shoulder PJI, in whom all prosthetic components are removed.
* The standard treatment for systemic and local antibiotics is followed (predetermined algorithm).
* Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments (at 3, 6 and 12 months after study inclusion).
Exclusion Criteria:
* Treatment with debridement and prosthesis retention (e.g. performed in early postoperative or acute hematogenous infections with symptom duration \<3 weeks) or one-stage exchange.
* PJI caused by difficult-to-treat organisms, including rifampin-resistant staphylococci, quinolone-resistant Gram-negative bacilli and fungi.
* Subject previously enrolled in this study or is currently enrolled in another competitive investigational study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02372435
Study Brief:
Protocol Section:
NCT02372435