The Diagnostic Pillar for Diagnosis of Infections in the Orthopedic Field: Smart and Sustainable Paper-based Electrochemical Point-of-care Device Assisted by Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •pregnant women,
- •patient affected by cancer
- •patient under antibiotic therapy
结局指标
主要结局
Sensitivity and Specificity
时间窗: at enrollement
Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis
次要结局
未报告次要终点
