Leukocyte Esterase Sensor Test
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04390607 |
Recruitment Status :
Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : September 23, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Prosthetic Joint Infection | Diagnostic Test: leukocyte esterase electrochemical assay |
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 |

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 |
- Receiver Operating Curve (ROC) analysis [ Time Frame: 20 minutes ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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.

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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections |