[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564859":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":23,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":23,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients who undergo total total knee arthroplasty","EXPERIMENTAL","The study population comprises 197 patients who require Total Knee Arthroplasty (TKA) due to symptomatic, end-stage knee osteoarthritis. Eligible participants are adults over the age of 18 years with functionally intact ligaments. Exclusion criteria include individuals with neurological or other conditions that affect their ability to participate in walking trials, those with inflammatory or infectious arthritis, previous significant knee surgeries such as articular fractures (excluding knee arthroscopy and meniscal surgery), and those with active tumors or who are pregnant. This population selection is aimed at assessing the efficacy of AI-integrated interventions in improving surgical outcomes and postoperative recovery in a homogeneous group affected by severe knee degeneration.",[13,14,15,16],"Procedure: Total Knee Arthroplasty","Diagnostic Test: Multifaceted diagnostic assessments","Behavioral: Follow-ups","Genetic: Genetic screening",[18,24,29,34],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Total Knee Arthroplasty","Total Knee Arthroplasty is performed using conventional surgical techniques.",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"DIAGNOSTIC_TEST","Multifaceted diagnostic assessments","Multifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations.",[9],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"BEHAVIORAL","Follow-ups","Postoperative follow-up includes behavioral interventions, such as lifestyle counseling and rehabilitation programs, tailored based on AI-driven insights into individual patient recovery profiles.",[9],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":23},"GENETIC","Genetic screening","Genetic screening and analysis, including whole exome sequencing, are conducted to identify genetic markers that might influence the outcomes of knee arthroplasty. This data is utilized within AI models to predict patient-specific surgical outcomes and recovery processes.",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Umile Giuseppe Longo, MD, MSc, PhD","CONTACT","+39 06225418816","g.longo@policlinicocampus.it",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":49,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Rome","Italy","00128","IT",{"type":53,"coordinates":54},"Point",[55,56],12.51133,41.89193,{"lat":56,"lon":55},[59],{"name":41,"role":60,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Umile Giuseppe Longo","Professor","100564859","an-artificial-intelligence-based-approach-in-total-knee-arthroplasty-from-inflammatory-responses-to-personalized-medicine-100564859",false,"NCT06634654","An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine","AI-TKA","Inclusion Criteria:\n\n1. Symptomatic, end-stage knee osteoarthritis\n2. Ligaments functionally intact\n3. Age: older than18 years old\n\nExclusion Criteria:\n\n1. Neurological or other conditions affecting patients ability to join walking trials\n2. Inflammatory or infectious arthritis\n3. Previous articular fracture or knee surgery (excluding knee arthroscopy and meniscal surgery)\n4. Active tumors or pregnancy.","ALL","18 Years",{"count":74,"type":75},197,"ESTIMATED","INTERVENTIONAL",[78],"NA","Goal: The goal of this interventional study is to understand how multimodal preoperative data can predict outcomes after Total Knee Arthroplasty (TKA) and improve personalized medicine practices.\n\nParticipant Population: The study will enroll 197 patients suffering from symptomatic, end-stage knee osteoarthritis, who are above 18 years old and have functionally intact ligaments.\n\nMain Questions:\n\n* Can multimodal preoperative data, genetic predisposition, and psycho-behavioral characteristics predict outcomes after TKA?\n* Can AI models effectively use this data to customize prostheses and surgical interventions, and predict patient outcomes? Comparison Group Information (If applicable): Not specified in the provided details.\n\nParticipant Tasks:\n\n* Undergo TKA as per the normal clinical routine.\n* Participate in pre- and post-surgical follow-ups including:\n* Clinical-functional assessments.\n* Administration of clinical scores.\n* Collection of biological samples.\n* Biomechanical analysis using a stereophotogrammetric system.\n* Provide data for the comprehensive multimodal indexed database.",[81],"Knee Osteoarthritis",[83,20,84,85,86,87,88,89,81],"Artificial Intelligence","Biomechanics","Orthopaedic surgery","Alarmins","Oxidative Stress","Cytokine","Knee Inflammation","2026-03-02",{"date":92,"type":93},"2026-03-04","ACTUAL",{"date":95,"type":93},"2024-10-14",{"date":97,"type":75},"2029-12",{"name":5,"class":6},1]