Leukocyte Esterase Sensor Test

• Conditions: Prosthetic Joint Infection
• Interventions: Diagnostic Test: leukocyte esterase electrochemical assay

• Registration Number: NCT04390607
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23
• Study Start: 2020-11-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing revision joint surgery	leukocyte esterase electrochemical assay	-

Primary Outcome Measures

Name	Time	Method
Receiver Operating Curve (ROC) analysis	20 minutes

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States