Leukocyte Esterase Sensor Test

September 22, 2020 updated by: Rothman Institute Orthopaedics

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

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

Study Locations

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

Genders Eligible for Study

All

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).

Description

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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Receiver Operating Curve (ROC) analysis
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

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

Sponsor

Rothman Institute Orthopaedics

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 (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020Cleu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Prosthetic Joint Infection

Clinical Trials on leukocyte esterase electrochemical assay

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe