Leukocyte Esterase Sensor Test

Status unconfirmed

Conditions studied: Prosthetic Joint Infection

In brief

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.

Key facts

Study ID

NCT04390607

Run by

Rothman Institute Orthopaedics

People needed

230

Starts

2020-11-01

Expected to finish

2021-10-31

Last updated by the study team

2020-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection

You may not qualify if…

• known active gout flare
• existing corrosion or metallosis
• inflammatory arthritis
• preexisting diagnosis of infection in the same joint
• patients undergoing second-stage procedure for infection.

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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