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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT05440032
Eligibility Criteria:
Inclusion Criteria:
1. Age greater than 18 years
2. Willing and able to sign the informed consent document
3. Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.
Exclusion Criteria:
1. Subjects with known active crystalline deposition disease (e.g. gout)
2. Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
3. Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
4. Subjects undergoing a second-stage re-implantation procedure for PJI
5. Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.
6. Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05440032
Study Brief:
Protocol Section:
NCT05440032