Leukocyte Esterase Sensor Test

Rothman Institute Orthopaedics230 enrolled

Overview

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

Study Type

OBSERVATIONAL

Enrollment

230

Conditions

Prosthetic Joint Infection

Interventions

leukocyte esterase electrochemical assayDIAGNOSTIC_TEST

A sample of blood drawn for routine standard of care laboratory assessments will be used to also test the new electrochemical assay. This is a validation study and the results of the electrochemical assay will not be used to treat patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection Exclusion Criteria: 1. known active gout flare 2. existing corrosion or metallosis 3. inflammatory arthritis 4. preexisting diagnosis of infection in the same joint 5. patients undergoing second-stage procedure for infection.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Receiver Operating Curve (ROC) analysis

Time frame: 20 minutes

Data from ClinicalTrials.gov

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