[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503870":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Knee Ostetomy combined with meniscal allograft transplantation","EXPERIMENTAL","The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.",[13],"Procedure: Knee osteotomy associated with meniscal allograft transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Knee Osteotomy","ACTIVE_COMPARATOR","The control group will consist of patients who will perform an isolated osteotomy.",[19],"Procedure: Knee osteotomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Knee osteotomy associated with meniscal allograft transplantation","Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.",[9],null,{"type":22,"name":28,"description":28,"armGroupLabels":29,"otherNames":26},"Knee osteotomy",[15],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Alessandro Di Martino, MD","CONTACT","6366567","051","roberta.licciardi@ior.it",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":36},"Roberta Licciardi, MSc",[40],{"facility":5,"status":41,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Bologna","40136","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],11.33875,44.49381,{"lat":50,"lon":49},[53,56,57,60],{"name":54,"role":33,"phone":34,"phoneExt":26,"email":55},"Alessandro Di Martino","alessandro.dimartino@ior.it",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":36},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Gina Lisignoli, PhD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":26,"phoneExt":26,"email":26},"Claudio Belvedere, Eng",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100503870","knee-osteotomy-associated-with-allograft-meniscus-transplantation-100503870",false,"NCT05840887","Knee Osteotomy Associated With Allograft Meniscus Transplantation","Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation","Inclusion Criteria:\n\n1. Male or female patients aged between 20 and 60 years;\n2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);\n3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \\> 5°);\n4. Meniscal deficit of the compartment affected by the overload due to malalignment;\n5. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)\n6. Signature of informed consent\n\nExclusion Criteria:\n\n1. Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;\n2. Diagnosis of neoplastic diseases;\n3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;\n4. Patients with uncontrolled diabetes mellitus;\n5. Patients with uncontrolled thyroid metabolic disorders;\n6. Patients abusing alcoholic beverages, drugs or medications;\n7. Body Mass Index \\> 40;\n8. Pregnancy or lactation status or intention to become pregnant during the period of study participation;\n9. Patients undergoing knee surgery in the previous 12 months.","ALL","20 Years","60 Years",{"count":75,"type":76},52,"ESTIMATED","INTERVENTIONAL",[79],"NA","This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 allocation.\n\nThe main objective of the BIOMAT project is to demonstrate, through an RCT, whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment. Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration.",[82,83],"Malalignment, Bone","Osteoarthritis, Knee",[85,86,87],"knee osteotomy","MAT","meniscal allograft transplatation","2025-12-03",{"date":90,"type":91},"2025-12-04","ACTUAL",{"date":93,"type":91},"2023-08-30",{"date":95,"type":76},"2026-06",{"name":5,"class":6},1]