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| Name | Class |
|---|---|
| Ministero della Salute, Italy | OTHER |
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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 samples will be analysed using Ortho-PoC at three different Hospitals (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedali Riuniti di Foggia, Azienza Ospedaliera Universitaria Policlinico Vanvitelli Napoli) and the data will be treated with artificial intelligence (AI) to deliver an AI-assisted robust, effective, and smart diagnostic device for PJI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infection Group | Patients affected by PJI and Spondylodiscitis |
| |
| Control Group | Patients with post-contusive or inflammatory or arthritic suffusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device | Device | Use of the device in groups to test its ability to diagnose infections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis | at enrollement |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a suspected history of PJI or spondylodiscitis according to international guidelines and subsequent diagnostic confirmation of infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raffaele Vitiello, MD PhD | Contact | +39 - 0630151 | raffaele.vitiello@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Giulio Maccauro | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
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| ID | Term |
|---|---|
| D015299 | Discitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D001850 | Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| D013122 |
| Spinal Diseases |