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

NCT ID: NCT06666023

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 UniversitĂ  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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PJI Spondylodiscitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Infection Group

Patients affected by PJI and Spondylodiscitis

Device

Intervention Type DEVICE

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

Control Group

Patients with post-contusive or inflammatory or arthritic suffusion

Device

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Device

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministero della Salute, Italy

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giulio Maccauro

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondazione Policlinico Gemelli IRCCS

Rome, Lazio, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Raffaele Vitiello, MD PhD

Role: CONTACT

+39 - 0630151

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raffaele Vitiello, MD PhD

Role: primary

+390630155701

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PNRR-POC-2023-12378291

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.