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
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.
Study Type
OBSERVATIONAL
Enrollment
160
Electrochemical assay to detect level of leukocyte esterase in sample
Urinalysis chemstrip
Colorado Joint Replacement
Denver, Colorado, United States
NOT_YET_RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
NOT_YET_RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)
Time frame: Within one hour of fluid aspiration
Correlation of leukocyte esterase and synovial white blood cell count
Time frame: Within 30 days of surgery
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New York University
New York, New York, United States
NOT_YET_RECRUITINGUniversity of Rochester
Rochester, New York, United States
NOT_YET_RECRUITINGJIS Orthopaedics
New Albany, Ohio, United States
NOT_YET_RECRUITINGRothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGWest Virginia University
Morgantown, West Virginia, United States
RECRUITING