Leukocyte Esterase Sensor Test

NCT ID: NCT04390607

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Prosthetic Joint Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects undergoing revision joint surgery

leukocyte esterase electrochemical assay

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Facility Contacts

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Daniel Waren, MSPH

Role: primary

954-559-2251

Other Identifiers

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2020Cleu

Identifier Type: -

Identifier Source: org_study_id

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