Trials / Unknown
UnknownNCT04390607
Leukocyte Esterase Sensor Test
A Research Study to Determine if a Leukocyte Esterase Electrochemical Assay Can be Used as a Marker for Periprosthetic Joint Infection
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 230 (estimated)
- Sponsor
- Rothman Institute Orthopaedics · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2021-09-30
- Completion
- 2021-10-31
- First posted
- 2020-05-15
- Last updated
- 2020-09-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04390607. Inclusion in this directory is not an endorsement.