LE as a Marker for Periprosthetic Joint Infection

January 29, 2024 updated by: Center for Innovation and Research Organization

Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection

Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Not yet recruiting
        • Colorado Joint Replacement
        • Contact:
          • Clinical Research Manager
          • Phone Number: 303-260-2940
    • Florida
      • Weston, Florida, United States, 33331
        • Not yet recruiting
        • Cleveland Clinic Florida
        • Contact:
          • Clinical Research Coordinator
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Not yet recruiting
        • University of Louisville
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 65585 502-587-8222
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • New York University
        • Contact:
          • Clinical Research Manager
          • Phone Number: 212-598-6245
      • Rochester, New York, United States, 14618
        • Not yet recruiting
        • University of Rochester
        • Contact:
          • Clinical Research Manager
          • Phone Number: 585-341-9303
    • Ohio
      • New Albany, Ohio, United States, 43054
        • Not yet recruiting
        • JIS Orthopaedics
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 614-964-0348
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Rothman Orthopaedic Institute
        • Contact:
          • Clinical Research Coordinator
          • Phone Number: 267-339-3613
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
          • Clinical Research Manager
          • Phone Number: 304-293-2485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing planned aseptic revision surgery to replace part or all of their hip or knee implant or subjects undergoing planned revision for infection

Description

Inclusion Criteria:

  1. Age greater than 18 years
  2. Willing and able to sign the informed consent document
  3. Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.

Exclusion Criteria:

  1. Subjects with known active crystalline deposition disease (e.g. gout)
  2. Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
  3. Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
  4. Subjects undergoing a second-stage re-implantation procedure for PJI
  5. Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.
  6. Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Synovial fluid testing with semi-quantitative leukocyte esterase test strip
Using a drop of synovial fluid, sample will be analyzed via the point-of-care device to measure amount of leukocyte esterase in the sample
Diagnostic test: Semi-quantitative electrochemical leukocyte esterse test strip
Electrochemical assay to detect level of leukocyte esterase in sample
Synovial fluid testing with Roche Chemstrip
Using a drop of synovial fluid, sample will be analyzed via a urine test-strip to measure amount of leukocyte esterase in the sample
Diagnostic test: Roche Chemstrip
Urinalysis chemstrip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)
Time Frame: Within one hour of fluid aspiration
Within one hour of fluid aspiration

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of leukocyte esterase and synovial white blood cell count
Time Frame: Within 30 days of surgery
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Innovation and Research Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LE001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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