NCT05440032

LE as a Marker for Periprosthetic Joint Infection

Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Center for Innovation and Research Organization · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.

Conditions

• Prosthetic-joint Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Semi-quantitative electrochemical leukocyte esterse test strip	Electrochemical assay to detect level of leukocyte esterase in sample
DIAGNOSTIC_TEST	Roche Chemstrip	Urinalysis chemstrip

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-06-30
• Last updated: 2024-01-30

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study