Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections
Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. Ortho-PoC will face this issue wit
| Condition(s) | PJI, Spondylodiscitis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. Ortho-PoC will face this issue with a smart and highly innovative diagnostic tool, starting from the point-of-care device for infection diagnosis in the orthopedic field developed and published by the coordinator Fondazione Policlinico Universitario Agostino Gemelli IRCCS and one partner Università degli Studi di Roma Tor Vergata. Ortho-PoC will further go beyond the state of the art by delivering a point-of-care device based on multiparametric analysis, in easily collected synovial fluids or pus. Several sam |
| Who can participate | Inclusion Criteria: * patients that received a joint implant or spine surgery, clear signs of infection (according to international guidelines) * patients off antibiotic therapy at least for two weeks * Sample biopsy of minimum 1 ml. Exclusion Criteria: * pregnant women, * patient affected by cancer * patient under antibiotic therapy |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Locations | Rome, Lazio, Italy |
| Start date | 2024-09-01 |
| NCT ID | NCT06666023 |
| Official listing | https://clinicaltrials.gov/study/NCT06666023 |