Leukocyte Esterase Sensor Test | NCT04390607

Studies
Leukocyte Esterase Sensor Test

NCT04390607

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Sep 23, 2020Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

Prosthetic Joint Infection

Interventions

leukocyte esterase electrochemical assay

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Oct 31, 2021Estimated

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2020

Last Update Posted Date

Sep 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects undergoing revision joint surgery			Diagnostic Test: leukocyte esterase electrochemical assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
leukocyte esterase electrochemical assay	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

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

Eligibility Module

Eligibility 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:

known active gout flare
existing corrosion or metallosis
inflammatory arthritis
preexisting diagnosis of infection in the same joint
patients undergoing second-stage procedure for infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample