[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564859":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":73,"studyPopulation":65,"armGroups":74,"interventions":84,"overallOfficials":65,"centralContacts":105,"locations":111,"responsibleParty":127,"collaborators":65,"id":130,"slug":65,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":65,"enrollmentInfo":138,"targetDuration":65,"studyType":141,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":113,"whyStopped":65,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":65},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Knee Society Score (KSS) at 12 months","The KSS is a clinician-based assessment tool that evaluates both knee function and functional activities after knee replacement surgery.\n\nMinimum\u002FMaximum Values: The KSS is divided into two parts: knee score and function score, with a combined score ranging from 0 to 100. Higher scores indicate a better outcome in terms of knee function and overall knee health.","Before surgery (Baseline) and at 12 months postoperatively",{"measure":14,"description":15,"timeFrame":12},"Change From Baseline in Oxford Knee Score (OKS) at 12 months","The OKS is used to assess pain and function in individuals undergoing knee surgery or experiencing knee osteoarthritis, focusing on the patient\\'s perspective.\n\nMinimum\u002FMaximum Values: The OKS ranges from 0 to 48. Higher scores represent a better outcome, with less pain and better joint function.",{"measure":17,"description":18,"timeFrame":12},"Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months","The KOOS is widely used to evaluate short- and long-term patient-reported outcomes following knee injury or surgery.\n\nMinimum\u002FMaximum Values: The KOOS assesses five dimensions: pain, symptoms, function in daily living, function in sports\u002Frecreation, and knee-related quality of life. Each subscale ranges from 0 to 100. Higher scores reflect a better outcome, indicating fewer symptoms and better function.",{"measure":20,"description":21,"timeFrame":12},"Change From Baseline in Forgotten Joint Score Short Form (FJS-12) at 12 months","The FJS-12 measures how much a patient is aware of their joint in daily activities, particularly after joint replacement surgery, with higher scores reflecting greater joint integration.\n\nMinimum\u002FMaximum Values: The FJS-12 ranges from 0 to 100. High scores indicate good outcomes",[23,26,29,32,35,38,41,44,47,50,53,57,60,63],{"measure":24,"description":25,"timeFrame":12},"Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months","The WOMAC is commonly used to evaluate pain, stiffness, and physical function in patients with osteoarthritis, particularly in the knee and hip.\n\nMinimum\u002FMaximum Values: The WOMAC ranges from 0 to 96. High scores indicate best functional status level",{"measure":27,"description":28,"timeFrame":12},"Change from baseline in knee range of motion (ROM) at 12 months","Knee joint ROM (measured in degree) will be assessed during gait using a 3D motion capture system",{"measure":30,"description":31,"timeFrame":12},"Change from baseline in ground reaction forces at 12 months","Ground reaction forces (measured in Newtons) during gait will be measured using force platforms synchronized with the 3D motion capture system",{"measure":33,"description":34,"timeFrame":12},"Change from baseline in center of pressure (CoP) at 12 months","The CoP (measured in meters) will be measured during gait using force platforms synchronized with the 3D motion capture system",{"measure":36,"description":37,"timeFrame":12},"Change from baseline in walking speed at 12 months","Walking speed (measured in meters per seconds) will be extracted using force platforms synchronized with the 3D motion capture system",{"measure":39,"description":40,"timeFrame":12},"Change from baseline in cadence at 12 months","Cadence (measured in steps per minute) will be assessed during gait using force platforms synchronized with the 3D motion capture system",{"measure":42,"description":43,"timeFrame":12},"Change from baseline in Step and Stride Length at 12 months","Step and Stride length (measured in meters) will be evaluate during gait using force platforms synchronized with the 3D motion capture system",{"measure":45,"description":46,"timeFrame":12},"Change from baseline in osteoarthritis (OA) severity based on the Kellgren-Lawrence score at 12 months","The severity of OA will be assessed using the Kellgren-Lawrence global radiographic score. Changes in OA severity will be graded on a scale from 0 to 4, with 0 indicating no OA and 4 indicating severe OA",{"measure":48,"description":49,"timeFrame":12},"Change from baseline in joint alignment at 12 months","The changes in joint alignment (measured in degrees) will be evaluated using X-rays to determine any shifts in anatomical alignment post-surgery",{"measure":51,"description":52,"timeFrame":12},"Change from baseline in lateral distal femoral angle at 12 months","The lateral distal femoral angle (measured in degrees) will be measured using X-rays to assess the alignment of the femur",{"measure":54,"description":55,"timeFrame":56},"Change from baseline in medial proximal tibial angle at 12 months","The medial proximal tibial angle will be measured to evaluate tibial alignment. X-rays will be used to assess changes in medial proximal tibial angle (measured in degrees)","Baseline (before surgery) and 12 months postoperatively",{"measure":58,"description":59,"timeFrame":12},"Change from baseline in joint line convergence angle at 12 months","The joint line convergence angle (measured in degrees) will be measured using X-rays to evaluate the alignment of the knee joint",{"measure":61,"description":62,"timeFrame":12},"Change from baseline in tibial slope at 12 months","The tibial slope (measured in degrees) will be assessed using X-rays to measure the posterior inclination of the tibial plateau",{"measure":64,"description":65,"timeFrame":66},"Change From Baseline in the fecal microbiota profiles at 12 months",null,"Before surgery and at 12 months postoperatively",{"allocation":68,"interventionModel":69,"interventionModelDescription":65,"primaryPurpose":70,"observationalModel":65,"timePerspective":65,"maskingInfo":71},"NA","SINGLE_GROUP","TREATMENT",{"masking":72,"maskingDescription":65,"whoMasked":65},"NONE","Osteoarthritis is one of the most common causes of knee disorders, leading to pain, reduced mobility, and a decline in quality of life. Total knee arthroplasty (TKA) is one of the most established treatments for end-stage osteoarthritis. Despite advancements in surgical techniques, patient dissatisfaction remains high. After surgery, patients often experience swelling, pain, and difficulty with daily activities. Revision surgery is a major challenge, with aseptic loosening occurring in 15-20% of cases. Given the high disability rates and healthcare costs associated with TKA, optimizing patient care is crucial.\n\nArtificial intelligence (AI) offers the potential to identify new care profiles. For the first time, AI can integrate multimodal datasets. This approach could lead to personalized treatment for knee osteoarthritis patients, in line with precision medicine principles. This study takes a multidisciplinary approach to better understand the causes of failure and dissatisfaction following TKA.\n\nThe primary aim of this study is is to create a multimodal database. This database will include structural, genetic, biomechanical, clinical, psychological, biological, stress-related, inflammatory, and demographic data. Using AI, the study aims to build predictive models for post-TKA outcomes. Insights from this research could improve patient management and lead to new therapeutic approaches.\n\nPatients suffering from knee osteoarthritis at Fondazione Policlinico Universitario Campus Bio-Medico will be enrolled in this study if they meet the inclusion\u002Fexclusion criteria described above.\n\nThere are no risks for the patients recruited in the study. The total duration of the study is 5 years. The enrolment of patients will start on the 01\u002F10\u002F2024 and will last 12 months for each patient.\n\nThe Italian Ministry of Health and the Fondazione Policlinico Universitario Campus Bio-Medico supported this study.\n\nThe PI and also the main contact of this study is professor Umile Giuseppe Longo.",[75],{"label":76,"type":77,"description":78,"interventionNames":79},"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.",[80,81,82,83],"Procedure: Total Knee Arthroplasty","Diagnostic Test: Multifaceted diagnostic assessments","Behavioral: Follow-ups","Genetic: Genetic screening",[85,90,95,100],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":65},"PROCEDURE","Total Knee Arthroplasty","Total Knee Arthroplasty is performed using conventional surgical techniques.",[76],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":65},"DIAGNOSTIC_TEST","Multifaceted diagnostic assessments","Multifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations.",[76],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":65},"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.",[76],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":65},"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.",[76],[106],{"name":107,"role":108,"phone":109,"phoneExt":65,"email":110},"Umile Giuseppe Longo, MD, MSc, PhD","CONTACT","+39 06225418816","g.longo@policlinicocampus.it",[112],{"facility":5,"status":113,"city":114,"state":115,"zip":116,"country":115,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"RECRUITING","Rome","Italy","00128","IT",{"type":119,"coordinates":120},"Point",[121,122],12.51133,41.89193,{"lat":122,"lon":121},[125],{"name":107,"role":126,"phone":65,"phoneExt":65,"email":65},"PRINCIPAL_INVESTIGATOR",{"type":126,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Umile Giuseppe Longo","Professor","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":139,"type":140},197,"ESTIMATED","INTERVENTIONAL",[68],"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.",[145],"Knee Osteoarthritis",[147,87,148,149,150,151,152,153,145],"Artificial Intelligence","Biomechanics","Orthopaedic surgery","Alarmins","Oxidative Stress","Cytokine","Knee Inflammation","2026-03-02",{"date":156,"type":157},"2026-03-04","ACTUAL",{"date":159,"type":157},"2024-10-14",{"date":161,"type":140},"2029-12",{"name":5,"class":6},1]