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Leukocyte Esterase Sensor Test

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ClinicalTrials.gov Identifier: NCT04390607
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment
Prosthetic Joint Infection Diagnostic Test: leukocyte esterase electrochemical assay

Study Design
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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : October 31, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects undergoing revision joint surgery 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


Outcome Measures
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Primary Outcome Measures :
  1. Receiver Operating Curve (ROC) analysis [ Time Frame: 20 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This will be a prospective study with consecutive revision joint surgery patients determined to be in one of three groups: 1) patients undergoing revision joint replacement for presumed aseptic loosening, 2) patients undergoing irrigation and debridement with implant retention, and 3) patients undergoing two stage revision for infection. We will also recruit a small number of patients undergoing primary joint replacement (Jefferson hospital only).
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390607


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10003
Contact: Daniel Waren, MSPH    954-559-2251    daniel.waren@nyulangone.org   
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04390607    
Other Study ID Numbers: 2020Cleu
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection