RECRUITING

LE as a Marker for Periprosthetic Joint Infection

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-12-07

Study Completion:2024-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05440032

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Tiffany Morrison

CONTACT

717-856-1202

tiffany@parvizisurgical.com

Study Locations (Sites)

Colorado Joint Replacement

Denver, Colorado, 80210

United States

Cleveland Clinic Florida

Weston, Florida, 33331

United States

University of Louisville

Louisville, Kentucky, 40202

United States

New York University

New York, New York, 10016

United States

University of Rochester

Rochester, New York, 14618

United States

JIS Orthopaedics

New Albany, Ohio, 43054

United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Center for Innovation and Research Organization

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07

Study Completion Date2024-03

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2024-03

Terms related to this study

Additional Relevant MeSH Terms

Prosthetic-joint Infection