[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585707":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":25,"id":59,"slug":25,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Federal University of São Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Corticoid","ACTIVE_COMPARATOR","The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient).\n\nIn this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.",[13],"Drug: Corticosteroid",{"label":15,"type":16,"description":17,"interventionNames":18},"platelet-rich fibrin","EXPERIMENTAL","The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them.\n\n10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.",[19],"Drug: Platelet-rich fibrin (PRF)",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","Platelet-rich fibrin (PRF)",[15],null,{"type":22,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"Corticosteroid",[9],[30],"corticoid",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Rodrigo A Mastrorosa, Dr","CONTACT","+55 11971105634","rodrigoamastrorosa@gmail.com",[38],{"facility":39,"status":25,"city":40,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Universidade Federal de São Paulo","São Paulo","04023-062","Brazil",{"type":44,"coordinates":45},"Point",[46,47],-46.63611,-23.5475,{"lat":47,"lon":46},[50,53],{"name":51,"role":34,"phone":52,"phoneExt":25,"email":36},"Rodrigo A Mastrorosa, DR","+55 11 971105634",{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"RODRIGO DE ALMEIDA MASTROROSA, DR","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rodrigo de Almeida Mastrorosa","Principal Investigator","100585707",false,"NCT06905860","Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis","iPRF","Inclusion Criteria:The following inclusion criteria will be followed:\n\n* Age 50 years or older\n* Who have not improved with non-surgical treatment for at least 3 months, ability to sign a consent form, average visual analog scale \\> 40\u002F100 (over at least 7 days in the previous month)\n* Mild or moderate knee osteoarthritis diagnosed by radiographic imaging grade 2 or 3 according to the Kellgren-Lawrence classification.\n\nExclusion Criteria: The exclusion criteria will be:\n\n-Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.\n\nThe following non-inclusion criteria will be observed:\n\n* Angular deviation \\>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia \\> 4º varus or \\> 16º valgus)\n* Body Mass Index (BMI)\\>35 or \\\u003C18\n* Smoking\n* Autoimmune inflammatory disease - rheumatological\n* Diabetes - with HbA1c \\> 7\n* Chronic kidney disease\n* Coagulopathies\n* severe cardiovascular diseases\n* infections or immunodeficiencies\n* active or treated malignant neoplasia\n* use of NSAIDs in the last month\n* use of corticosteroids in the last 3 months\n* platelets \\\u003C 150,000\n* recent intra-articular corticosteroid injection or recent HA injection (in the last 6 months)\n* pregnancy or suspected pregnancy\n* psychiatric disorders.",true,"ALL","50 Years",{"count":69,"type":70},90,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Methodology: Randomized double-blind clinical trial comparing intra-articular injection of Platelet-Rich Fibrin (PRF) versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale \\> 40\u002F100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation \\>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis \\> 4th varus or \\> 16th valgus), BMI \\>35 or \\\u003C18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb \\> 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies, malignant neoplasm in activity or under treatment, use of NSAIDs in the last month, use of corticosteroids in the last 3 months, platelets \\\u003C 150,000, recent intra-articular corticosteroid infiltration or recent Hyaluronic acid infiltration (within the last 6 months), pregnancy or suspected pregnancy, psychiatric disorders. Exclusion criteria: when one of the investigators considers that the participant may be simulating a worse health state than the real one in order to receive financial assistance with the absence from work, he will be excluded from the work. Primary outcome: WOMAC. Secondary outcomes: Visual Analogue Pain Scale. Evaluation moments: inclusion and after the procedure at 3, 6, 12, 18 and 24 months. Sample calculation: 90 patients, 45 patients in each group, considering 15% loss to follow-up and aiming to reach a power of 0.8 and an alpha value of 0.5.",[76],"Gonarthrosis; Primary",[78,79],"gonarthrosis","i-PRF","NOT_YET_RECRUITING","2025-03-24",{"date":83,"type":84},"2025-04-02","ACTUAL",{"date":86,"type":70},"2025-06-01",{"date":88,"type":70},"2027-09-01",{"name":5,"class":6},1]