LE as a Marker for Periprosthetic Joint Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-07

Study Completion Date

2024-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Prosthetic-joint Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Semi-quantitative electrochemical leukocyte esterse test strip

Intervention Type DIAGNOSTIC_TEST

Electrochemical assay to detect level of leukocyte esterase in 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

Roche Chemstrip

Intervention Type DIAGNOSTIC_TEST

Urinalysis chemstrip

Interventions

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Semi-quantitative electrochemical leukocyte esterse test strip

Electrochemical assay to detect level of leukocyte esterase in sample

Intervention Type DIAGNOSTIC_TEST

Roche Chemstrip

Urinalysis chemstrip

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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