T84.5
Conditions
Interventions
Group 1: Infection Confirmed (Case Group)
- Diagnostic cascade in suspected chronic periprosthetic infection, consisting of systemic blood laboratory analysis and joint aspiration, including routine a
Sponsors
Klinik für Orthopädie, Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Capacity to Consent - Treatment Diagnosis: Suspected PJI of knee or hip - Treatment Period: March 1, 2025, until the minimum case number is reached or for a maximum of 18–24 months (as stated above) - Surgical Site: Orthopedic University Hospital Heidelberg
Exclusion criteria
Exclusion criteria: - Periprosthetic infection of another joint - Infection of a native joint - Infection of soft tissues, bone, or osteosynthetic material without involvement of an - - implanted prosthesis - Revision of a prosthesis due to another cause (e.g., aseptic loosening, etc.) - Lack of consent capability or consent form from participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The classification of "case" versus "control" is made once this is feasible based on the current PJI definitions (ICM 2018, EBJIS criteria 2021). Subsequently, the primary endpoints 1 and 2 will be evaluated. For the third endpoint, a minimum follow-up of 12 months after the completion of diagnostic procedures has been established. 1. Evaluation of the reliability and accuracy (sensitivity, specificity, as well as positive and negative predictive values) for pathogen identification and diagnosis between Next-Generation Sequencing (NGS), commercial multiplex PCR, culture, and in-house 16S PCR. Hypothetical assessment of the resulting clinical impact based on correct diagnosis and pathogen identification. 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 (blood, synovial fluid). Determination of optimal cut-off values using Receiver Operating Characteristic (ROC) curves. 3. Evaluation of Infection Clearance versus Persistent Infection: Assessment of the reliability and accuracy (sensitivity, specificity, as well as positive and negative predictive values) regarding infection eradication versus persistent infection before and during reimplantation. Parameters analyzed include those mentioned in points 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-Reported Outcomes and Clinical Success Collection and Analysis of Standardized Routine Questionnaires at three time points (preoperatively, during the interim period, and approximately 12 months after reimplantation). - 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. Evaluation of Treatment Success and Complications after a minimum follow-up of 12 months after reimplantation - Based on Delphi Consensus Criteria and MSIS Criteria (2019) - Reimplantation rates, reinfection rates, reoperation rates - Surgical and medical complications, including mortality | — |
Countries
Germany
Contacts
Public ContactAndre Lunz
Klinik für Orthopädie, Universitätsklinikum Heidelberg
Outcome results
None listed