Leukocyte Esterase Sensor Test

A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04390607

Enrollment

230

Registered

2020-05-15

Start date

2020-11-01

Completion date

2021-10-31

Last updated

2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection

Brief summary

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.

Interventions

DIAGNOSTIC_TESTleukocyte esterase electrochemical assay

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Receiver Operating Curve (ROC) analysis	20 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026