LE as a Marker for Periprosthetic Joint Infection

NCT05440032 | Unknown FDA Device

• 1 other identifier: LE001
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 8

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

Conditions

Prosthetic-joint Infection

Outcome Measures

Primary Outcomes (1)

• Qualitative agreement (Positive, Intermediate, or Negative) between the semi-quantitative electrochemical LE test and Roche Chemstrip® LE test (Negative, Trace, 1+, or 2+)

  Within one hour of fluid aspiration

Secondary Outcomes (1)

• Correlation of leukocyte esterase and synovial white blood cell count

  Within 30 days of surgery

Study Arms (2)

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

Diagnostic Test: Semi-quantitative electrochemical leukocyte esterse test strip

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

Diagnostic Test: Roche Chemstrip

Interventions

Semi-quantitative electrochemical leukocyte esterse test strip DIAGNOSTIC_TEST

Electrochemical assay to detect level of leukocyte esterase in sample

Synovial fluid testing with semi-quantitative leukocyte esterase test strip

Roche Chemstrip DIAGNOSTIC_TEST

Urinalysis chemstrip

Synovial fluid testing with Roche Chemstrip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing planned aseptic revision surgery to replace part or all of their hip or knee implant or subjects undergoing planned revision for infection

You may qualify if:

• Age greater than 18 years
• Willing and able to sign the informed consent document
• 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.

You may not qualify if:

• Subjects with known active crystalline deposition disease (e.g. gout)
• Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
• Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
• Subjects undergoing a second-stage re-implantation procedure for PJI
• 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.
• Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.

Sponsors & Collaborators

• Center for Innovation and Research Organization: lead

Study Sites (8)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

NOT YET RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

NOT YET RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

New York University

New York, New York, 10016, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14618, United States

NOT YET RECRUITING

JIS Orthopaedics

New Albany, Ohio, 43054, United States

NOT YET RECRUITING

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Central Study Contacts

Tiffany Morrison

CONTACT

717-856-1202; tiffany@parvizisurgical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: December 7, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (8)