Leukocyte Esterase Sensor Test

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Prosthetic Joint Infection

Treatments: Diagnostic Test: leukocyte esterase electrochemical assay

Study type: Observational

Funder types: Other

Identifiers

NCT04390607

2020Cleu

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

230 participants in 1 patient group

Subjects undergoing revision joint surgery

Treatment:

Diagnostic Test: leukocyte esterase electrochemical assay