T84.5
Conditions
Interventions
Group 1: Extracorporeal Shock Wave–Assisted Synovial Aspiration
Group 2: SHAM-Extracorporeal Shock Wave–Assisted Synovial Aspiration
Sponsors
MUM – Muskuloskelettales Universitätszentrum München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Suspected periprosthetic joint infection (PJI) based on clinical and laboratory criteria (e.g., elevated CRP, local signs of infection, imaging findings according to EBJS criteria) Indication for preoperative diagnostic joint aspiration Able to provide informed consent
Exclusion criteria
Exclusion criteria: Open wounds or fistulas in the area of shock wave application Coagulation disorders or contraindications to ESWT Pregnancy or patients with cardiac pacemakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of positive microbiological cultures from preoperative joint aspirate (ESWT vs. control). | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance between preoperative aspirate cultures and intraoperative tissue/implant cultures Pathogen profile (in particular detection of low-virulence species such as Cutibacterium acnes, Staphylococcus epidermidis) Safety and tolerability of ESWT (pain, hematomas, local reactions) Correlation with molecular diagnostic methods (PCR, if applicable NGS) | — |
Countries
Germany
Contacts
Public ContactJannis Kornilakis
MUM – Muskuloskelettales Universitätszentrum München
Outcome results
None listed