Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections

ConditionsPJI Spondylodiscitis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

pregnant women,

patient affected by cancer

patient under antibiotic therapy

Trial population

Patients with a suspected history of PJI or spondylodiscitis according to international guidelines and subsequent diagnostic confirmation of infection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Device
Device
Use of the device in groups to test its ability to diagnose infections.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Infection Group1 intervention

Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

Sensitivity and Specificity

Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis

Time frame

at enrollement

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Ministero della Salute, Italy

Collaborator

Source ClinicalTrials.gov

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