Testing a new test for joint infections after surgery

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

This study is testing a new way to quickly check for joint infections after surgery in people who might need surgery for hip or knee issues to see if it works as well as the current standard test.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Center for Innovation and Research Organization (Research network)
• Locations: 8 sites (Denver, Colorado and 7 other locations)
• Trial ID: NCT05440032 on ClinicalTrials.gov

What this trial studies

This study evaluates a new point-of-care electrochemical assay for detecting periprosthetic joint infections (PJI) in hip and knee joints, comparing its effectiveness to the standard Roche Chemstrip leukocyte esterase test. The primary goal is to determine if the new test is equivalent to the standard test in diagnosing PJI using synovial fluid samples. Additionally, the study will analyze the correlation between leukocyte esterase levels and synovial white blood cell counts as a secondary reference. Participants will include those with suspected joint infections or failures who are scheduled for surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with suspected periprosthetic joint infections or aseptic failures requiring surgical intervention.

Not a fit: Patients with known active crystalline deposition diseases, adverse local tissue reactions, or active inflammatory arthropathies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster and more accurate diagnosis of joint infections, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using similar diagnostic approaches, but this specific method is relatively novel.

Eligibility 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.

Where this trial is running

Denver, Colorado and 7 other locations

• Colorado Joint Replacement — Denver, Colorado, United States (Not_yet_recruiting)
• Cleveland Clinic Florida — Weston, Florida, United States (Not_yet_recruiting)
• University of Louisville — Louisville, Kentucky, United States (Not_yet_recruiting)
• New York University — New York, New York, United States (Not_yet_recruiting)
• University of Rochester — Rochester, New York, United States (Not_yet_recruiting)
• JIS Orthopaedics — New Albany, Ohio, United States (Not_yet_recruiting)
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Tiffany Morrison

Conditions Prosthetic-joint Infection