LE as a Marker for Periprosthetic Joint Infection

Study Purpose

Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age greater than 18 years. 2. Willing and able to sign the informed consent document. 3. Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.

Exclusion Criteria:

1. Subjects with known active crystalline deposition disease (e.g. gout) 2. Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip. 3. Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis) 4. Subjects undergoing a second-stage re-implantation procedure for PJI. 5. Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed. 6. Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05440032
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Center for Innovation and Research Organization
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Prosthetic-joint Infection

Additional Details

The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.

Arms & Interventions

Arms

: Synovial fluid testing with semi-quantitative leukocyte esterase test strip

Using a drop of synovial fluid, sample will be analyzed via the point-of-care device to measure amount of leukocyte esterase in the sample

: Synovial fluid testing with Roche Chemstrip

Using a drop of synovial fluid, sample will be analyzed via a urine test-strip to measure amount of leukocyte esterase in the sample

Interventions

Diagnostic Test: - Semi-quantitative electrochemical leukocyte esterse test strip

Electrochemical assay to detect level of leukocyte esterase in sample

Diagnostic Test: - Roche Chemstrip

Urinalysis chemstrip

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Joint Replacement, Denver, Colorado

Status

Not yet recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Site Contact

Clinical Research Manager

[email protected]

303-260-2940

Cleveland Clinic Florida, Weston, Florida

Status