LE as a Marker for Periprosthetic Joint Infection

Description

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

Conditions

Prosthetic-joint Infection

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Study Overview

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Study Details

Study overview

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

Electrochemical Test of Leukocyte Esterase as a Marker for Periprosthetic Joint Infection

LE as a Marker for Periprosthetic Joint Infection

Condition
Prosthetic-joint Infection
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Joint Replacement, Denver, Colorado, United States, 80210

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

New York

New York University, New York, New York, United States, 10016

Rochester

University of Rochester, Rochester, New York, United States, 14618

New Albany

JIS Orthopaedics, New Albany, Ohio, United States, 43054

Philadelphia

Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, United States, 19107

Morgantown

West Virginia University, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Center for Innovation and Research Organization,

Study Record Dates

2024-03