Evaluating calprotectin levels in joint fluid to diagnose infections in artificial joints
Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection
This study is testing if measuring calprotectin levels in joint fluid can help doctors tell the difference between infections and other problems in artificial joints for people needing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT05060952 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of prosthetic joint infections by comparing calprotectin levels in joint fluid from infected joints versus those with other complications. The study hypothesizes that higher levels of calprotectin in infected joints can aid in distinguishing infections from other issues like loosening or instability. Participants will be individuals scheduled for arthroplasty exchange due to various complications, excluding those with acute infections. The calprotectin lateral flow test will be utilized to assess the inflammatory protein levels.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for arthroplasty exchange due to infection, loosening, instability, malalignment, or periprosthetic fracture.
Not a fit: Patients with acute prosthetic joint infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of prosthetic joint infections, potentially reducing the need for unnecessary surgeries.
How similar studies have performed: While the approach of using calprotectin for diagnosis is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled arthroplasty exchange for any of the following reasons: * infection * loosening * instability * malalignment * periprosthetic fracture Exclusion Criteria: * acute prosthetic joint infection
Where this trial is running
Munich, Bavaria
- Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Christian Suren, M.D.
- Email: christian.suren@tum.de
- Phone: +49 89 4140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.