Acute Joint Infektions (including native joints and periprosthetic joint infections)
Conditions
Interventions
Group 1: Infection confirmed (case group)
-diagnostic pathway for suspected acute septic arthritis includes systemic blood tests and synovial fluid analysis, including the diagnostic routine and study
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Treatment Diagnosis: Suspected Acute Joint Infection • Anatomical Location: Large joints (knee, hip, shoulder, ankle, elbow, wrist) • Treatment Procedure: Blood sampling and joint aspiration • Treatment Duration: Prospective study for a maximum of 18–24 months or until the required sample size of at least 80 patients per group is reached • Treatment Facility: Orthopaedic Department, University Hospital Heidelberg
Exclusion criteria
Exclusion criteria: • Chronic infections with a symptom duration exceeding six weeks • Infection of a different joint • Infection of soft tissue or bone without joint involvement • Lack of capacity to consent or absence of informed consent from participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of the reliability and accuracy (sensitivity, specificity, as well as positive and negative predictive values) and the timing of pathogen identification among commercial multiplex PCR, culture, and in-house PCR, along with a hypothetical assessment of the resulting clinical impact derived from correct diagnosis and earlier pathogen detection. 2. Evaluation of the reliability and accuracy (sensitivity, specificity, as well as positive and negative predictive values) of established and novel biomarkers for diagnostic purposes (in blood and synovial fluid), as well as determination of optimal cutoff values using Receiver Operating Characteristic (ROC) curves. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Collection and Analysis of Standardized Routine Questionnaires • Joint pain (VAS) and patient satisfaction (VAS) • Joint function (Oxford Hip and Knee Score, UCLA) • Health-related quality of life (EQ-5D, VR-12) 2. Assessment and Evaluation of Treatment Success Rates and Complications • Reinfection rates, reoperation rates, and reintervention rates • Surgical and medical complications | — |
Countries
Germany
Contacts
Public ContactAndre Lunz
Universitätsklinikum Heidelberg
Outcome results
None listed