LE as a Marker for Periprosthetic Joint Infection

Status unconfirmed

Conditions studied: Prosthetic-joint Infection

In brief

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

Key facts

Study ID

NCT05440032

Run by

Center for Innovation and Research Organization

People needed

160

Starts

2023-12-07

Expected to finish

2024-03-01

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West Virginia University — Morgantown, West Virginia, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• New York University — New York, New York, United States
• Colorado Joint Replacement — Denver, Colorado, United States
• JIS Orthopaedics — New Albany, Ohio, United States
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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