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NCT05440032 | RECRUITING | Prosthetic-joint Infection

LE as a Marker for Periprosthetic Joint Infection
Sponsor:

Center for Innovation and Research Organization

Brief Summary:

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

Condition or disease

Prosthetic-joint Infection

Intervention/treatment

Semi-quantitative electrochemical leukocyte esterse test strip

Roche Chemstrip

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 160 participants
Official Title : Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection
Actual Study Start Date : 2023-12-07
Estimated Primary Completion Date : 2024-03
Estimated Study Completion Date : 2024-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
LE as a Marker for Periprosthetic Joint Infection

Location Details

NCT05440032

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Colorado

Colorado Joint Replacement

Denver, Colorado, United States, 80210

NOT YET RECRUITING

United States, Florida

Cleveland Clinic Florida

Weston, Florida, United States, 33331

NOT YET RECRUITING

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

NOT YET RECRUITING

United States, New York

New York University

New York, New York, United States, 10016

NOT YET RECRUITING

United States, New York

University of Rochester

Rochester, New York, United States, 14618

NOT YET RECRUITING

United States, Ohio

JIS Orthopaedics

New Albany, Ohio, United States, 43054

NOT YET RECRUITING

United States, Pennsylvania

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, West Virginia

West Virginia University

Morgantown, West Virginia, United States, 26506