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NCT04390607 Clinical Trial

Leukocyte Esterase Sensor Test

Prosthetic Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04390607
Other study ID # 2020Cleu
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date October 31, 2021

Study information
Verified date September 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 230
Est. completion date October 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• leukocyte 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

Locations
Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Receiver Operating Curve (ROC) analysis 20 minutes
See also
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