Leukocyte Esterase Sensor Test

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04390607
• Collaborator: (none)
• Enrollment: 230
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 19.2

Study Details

Study Description

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	Phase
Prosthetic Joint Infection	Diagnostic Test: leukocyte esterase electrochemical assay

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Oct 31, 2021

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Receiver Operating Curve (ROC) analysis [20 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10003

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04390607
• Other Study ID Numbers: 2020Cleu
• First Posted: May 15, 2020
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

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

Study Results

No Results Posted as of Sep 23, 2020