[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644496":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":41,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"PTG",null,"Subjects eligible among patients scheduled for primary total knee arthroplasty, in whom harvesting of the tibial plateau and\u002For femoral condyles and\u002For synovial tissue is planned",{"label":13,"type":10,"description":14,"interventionNames":10},"BMC","Concentrated bone marrow samples",{"label":16,"type":10,"description":17,"interventionNames":10},"PRP","Platelet-rich plasma samples",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"stefano zaffagnini","CONTACT","0516366075","stefano.zaffagnini@unibo.it",[25],{"facility":26,"status":10,"city":27,"state":10,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"IRCCS Rizzoli Orthopedic Institute","Bologna","40136","Italy","IT",{"type":32,"coordinates":33},"Point",[34,35],11.33875,44.49381,{"lat":35,"lon":34},[38],{"name":39,"role":21,"phone":22,"phoneExt":10,"email":40},"Stefano Zaffagnini","stefano.zaffagnini@ior.it",{"type":42,"investigatorFullName":39,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Full Professor Medicine and Surgery, University of Bologna","100644496","biological-evaluation-of-orthopedic-materials-an-in-vitro-study-using-patient-derived-human-samples-100644496",false,"NCT07671521","Biological Evaluation of Orthopedic Materials: An In Vitro Study Using Patient-Derived Human Samples","RAISE","Femoral condyle, tibial plateau and synovial membrane samples\n\nPatients undergoing primary total knee arthroplasty at the Orthopaedic and Trauma Clinic II of the IRCCS Istituto Ortopedico Rizzoli (Bologna, Italy), in whom collection of tibial plateau, femoral condyles and\u002For synovial tissue is planned.\n\nInclusion criteria:\n\nAge 18-80 years, male or female Primary tricompartmental osteoarthritis Body Mass Index (BMI) \\\u003C 35 Kellgren-Lawrence grade III-IV osteoarthritis Written informed consent\n\nExclusion criteria:\n\nPrevious partial knee arthroplasty or cartilage repair\u002Fregenerative procedures Rheumatoid arthritis or chronic corticosteroid\u002Fimmunosuppressive therapy Positive testing for HIV, HBV or HCV infection Concentrated bone marrow (BMC) samples\n\nPatients of both sexes providing written informed consent and presenting with the following characteristics:\n\nInclusion criteria:\n\nAge 18-70 years Medial compartment knee osteoarthritis (Kellgren-Lawrence grade II-III for \\>4 months) Failure of ≥6 months of conservative treatment (NSAIDs\u002Fanalgesics, hyaluronic acid, corticosteroid or PRP injections) Written informed consent\n\nExclusion criteria:\n\nInability to provide informed consent Knee trauma within the previous 6 months Malignancy, rheumatic disease, uncontrolled diabetes, uncontrolled thyroid disorders Alcohol or drug abuse BMI \\> 35 Intra-articular injections within the previous 6 months Knee surgery within the previous 12 months HIV, HBV or HCV positivity Platelet-rich plasma (PRP) samples\n\nPatients of both sexes with degenerative cartilage disease of the knee.\n\nInclusion criteria:\n\nAge 18-65 years Clinical signs and symptoms of knee cartilage degeneration Radiographic or MRI evidence of degeneration (Kellgren-Lawrence grade II-IV) Hemoglobin \\> 11 g\u002FdL Platelet count \\> 150,000\u002Fmm³ No clinically relevant ECG abnormalities Written informed consent\n\nExclusion criteria:\n\nRheumatoid arthritis or chronic corticosteroid\u002Fimmunosuppressive therapy Uncontrolled diabetes Hematological disorders or anticoagulant\u002Fantiplatelet therapy Thyroid metabolic disorders Alcohol, drug or medication abuse NSAID use within 3 days prior to blood draw Cardiovascular disease contraindicating a 150 mL blood draw HIV, HBV or HCV positivity","ALL","18 Years","80 Years",{"count":55,"type":56},50,"ESTIMATED","OBSERVATIONAL","The anterior cruciate ligament (ACL) is the primary stabilizer of the knee joint, and ACL injuries are highly prevalent, particularly among physically active and athletic individuals. Although ACL reconstruction is a well-established orthopedic procedure, significant challenges remain regarding biological integration between the graft and bone, which may negatively affect clinical outcomes.\n\nIn recent years, advanced biomaterials and regenerative medicine approaches have gained increasing attention as potential strategies to enhance osteointegration and promote more physiological tissue healing. Before clinical application, these materials must undergo rigorous in vitro biological evaluation in accordance with international standards, particularly ISO 10993-5 for cytotoxicity assessment.\n\nThe study will investigate cytotoxicity, cell viability, inflammatory responses, pro-fibrotic effects, and osteogenic potential using relevant human cell models. The regenerative effects of platelet-rich plasma (PRP), a source of growth factors, will also be evaluated.\n\nThe biomaterials under investigation include a titanium alloy and polylactic acid (PLA), both widely used in orthopedic applications. The main objective is to demonstrate their biocompatibility, absence of cytotoxic, inflammatory, and pro-fibrotic effects, and their ability to support osteogenic processes and tissue integration. The findings will provide essential evidence for subsequent preclinical in vivo studies and future clinical translation.",[60],"Cytotoxicity","NOT_YET_RECRUITING","2026-06-22",{"date":64,"type":65},"2026-06-26","ACTUAL",{"date":67,"type":56},"2026-07",{"date":69,"type":56},"2028-06",{"name":39,"class":6},1]