Status:
RECRUITING
LE as a Marker for Periprosthetic Joint Infection
Lead Sponsor:
Center for Innovation and Research Organization
Conditions:
Prosthetic-joint Infection
Eligibility:
All Genders
18+ years
Brief Summary
Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test
Detailed Description
The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) ...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Willing and able to sign the informed consent document
- 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
- Subjects with known active crystalline deposition disease (e.g. gout)
- Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
- Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
- Subjects undergoing a second-stage re-implantation procedure for PJI
- 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.
- Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05440032
Start Date
December 7 2023
End Date
March 1 2024
Last Update
January 30 2024
Active Locations (8)
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1
Colorado Joint Replacement
Denver, Colorado, United States, 80210
2
Cleveland Clinic Florida
Weston, Florida, United States, 33331
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
New York University
New York, New York, United States, 10016