[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595042":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":256,"collaborators":10,"id":258,"slug":10,"hasResults":259,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":10,"eligibilityCriteria":263,"healthyVolunteers":259,"sex":264,"minAge":265,"maxAge":10,"enrollmentInfo":266,"targetDuration":10,"studyType":269,"phases":10,"briefSummary":270,"conditions":271,"keywords":10,"overallStatus":187,"whyStopped":10,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},{"fullName":5,"class":6},"AO Foundation, AO Spine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OF score accordance group",null,"Initial treatment decision in accordance with the OF score recommendations",[13],"Procedure: Posterior stabilization (pedicle screws)",{"label":15,"type":10,"description":16,"interventionNames":17},"OF score discordance group","Initial treatment decision in discordance with the OF score recommendations",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Posterior stabilization (pedicle screws)","* Any other type of solely vertebral augmentation (stents, etc.), specify\n* Posterior stabilization (pedicle screws)\n* Posterior stabilization (pedicle screws) with kyphoplasty\u002Fvertebroplasty\n* Posterior stabilization (pedicle screws) with screw augmentation\n* Posterior stabilization (pedicle screws) with screw augmentation and kyphoplasty\u002Fvertebroplasty\n* Posterior stabilization (pedicle screws) with vertebral osteotomy (pedicle subtraction osteotomy or similar)\n* Combined posterior and anterior stabilization",[9,15],[25,26],"Kyphoplasty","Vertebroplasty",[28],{"name":29,"affiliation":30,"role":31},"Klaus Schnake, MD","Center for Spinal and Scoliosis Surgery","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Felix Thomas Thomas, PhD","CONTACT","+41 79 671 47 98","felix.thomas@aofoundation.org",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Maria C Medina Giner","0795456120","maria.medinaginer@aofoundation.org",[43,60,74,88,102,116,130,144,157,171,185,200,214,228,242],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of California San Francisco (USCF) Department of Orthopaedic Surgery","NOT_YET_RECRUITING","San Francisco","California","94143-0728","United States",{"type":51,"coordinates":52},"Point",[53,54],-122.41942,37.77493,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":10,"phoneExt":10,"email":59},"Ashraf El Naga, MD","ashraf.elnaga@ucsf.edu",{"facility":61,"status":45,"city":62,"state":63,"zip":64,"country":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107-4216",{"type":51,"coordinates":66},[67,68],-75.16362,39.95238,{"lat":68,"lon":67},[71],{"name":72,"role":35,"phone":10,"phoneExt":10,"email":73},"Alexander R Vaccaro, MD","alex.vaccaro@rothmaninstitute.com",{"facility":75,"status":45,"city":76,"state":10,"zip":77,"country":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Sanatorio Güemes","Buenos Aires","1240","Argentina",{"type":51,"coordinates":80},[81,82],-58.37723,-34.61315,{"lat":82,"lon":81},[85],{"name":86,"role":35,"phone":10,"phoneExt":10,"email":87},"Guillermo Ricciardi, MD","guillermoricciardi@gmail.com",{"facility":89,"status":45,"city":90,"state":10,"zip":91,"country":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Cajuru University Hospital","Curitiba","80050-50","Brazil",{"type":51,"coordinates":94},[95,96],-49.27306,-25.42778,{"lat":96,"lon":95},[99],{"name":100,"role":35,"phone":10,"phoneExt":10,"email":101},"Emiliano Vialle, MD","evialle@hotmail.com",{"facility":103,"status":45,"city":104,"state":10,"zip":105,"country":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Department of Orthopedic Surgery, Clinica Alemana de Santiago","Santiago","5951","Chile",{"type":51,"coordinates":108},[109,110],-70.64827,-33.45694,{"lat":110,"lon":109},[113],{"name":114,"role":35,"phone":10,"phoneExt":10,"email":115},"Ratko Yurac, MD","ryurac@gmail.com",{"facility":117,"status":45,"city":118,"state":10,"zip":119,"country":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine","Asyut","71526","Egypt",{"type":51,"coordinates":122},[123,124],31.18368,27.18096,{"lat":124,"lon":123},[127],{"name":128,"role":35,"phone":10,"phoneExt":10,"email":129},"Mohammad El-Sharkawi, MD","sharkoran@aun.edu.eg",{"facility":131,"status":45,"city":132,"state":10,"zip":133,"country":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Tampere University Hospital","Tampere","33521","Finland",{"type":51,"coordinates":136},[137,138],23.78712,61.49911,{"lat":138,"lon":137},[141],{"name":142,"role":35,"phone":10,"phoneExt":10,"email":143},"Marko Neva, MD","marko_neva@yahoo.com",{"facility":145,"status":45,"city":146,"state":10,"zip":147,"country":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien","Erlangen","91054","Germany",{"type":51,"coordinates":150},[151,152],11.00783,49.59099,{"lat":152,"lon":151},[155],{"name":29,"role":35,"phone":10,"phoneExt":10,"email":156},"Klaus.Schnake@waldkrankenhaus.de",{"facility":158,"status":45,"city":159,"state":10,"zip":160,"country":161,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"PGIMER - Postgraduate Institute of Medical Education and Research","Chandigarh","160 012","India",{"type":51,"coordinates":163},[164,165],76.7884,30.73629,{"lat":165,"lon":164},[168],{"name":169,"role":35,"phone":10,"phoneExt":10,"email":170},"Vishal Kumar, MD","drkumarvishal@gmail.com",{"facility":172,"status":45,"city":173,"state":10,"zip":174,"country":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Dokkyo Medical University Hospital","Tochigi","321-0293","Japan",{"type":51,"coordinates":177},[178,179],139.73333,36.38333,{"lat":179,"lon":178},[182],{"name":183,"role":35,"phone":10,"phoneExt":10,"email":184},"Masahito Takahata, MD","takahiroshm@yahoo.co.jp",{"facility":186,"status":187,"city":188,"state":10,"zip":189,"country":190,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Island Hospital Spine Centre","RECRUITING","George Town","10450","Malaysia",{"type":51,"coordinates":192},[193,194],100.33543,5.41123,{"lat":194,"lon":193},[197],{"name":198,"role":35,"phone":10,"phoneExt":10,"email":199},"Kim Soon Oh, MD","ohkimsoon@utar.edu.my",{"facility":201,"status":187,"city":202,"state":10,"zip":203,"country":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Spiatlul Clinic De Urgenta, \"Profesor Doctor Nicolae Oblu\"","Iași","700309","Romania",{"type":51,"coordinates":206},[207,208],27.6,47.16667,{"lat":208,"lon":207},[211],{"name":212,"role":35,"phone":10,"phoneExt":10,"email":213},"Eugen Cezar Popescu, MD","ciepopescu@yahoo.com",{"facility":215,"status":187,"city":216,"state":10,"zip":217,"country":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Security Force Hospital","Riyāḑ","11564","Saudi Arabia",{"type":51,"coordinates":220},[221,222],40.3,20.1,{"lat":222,"lon":221},[225],{"name":226,"role":35,"phone":10,"phoneExt":10,"email":227},"Ahmed Alzahrani, MD","ahmed_alzahrani_4@hotmail.com",{"facility":229,"status":45,"city":230,"state":10,"zip":231,"country":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Spital Emmental - Orthopädie Sonnenhof","Burgdorf","3400","Switzerland",{"type":51,"coordinates":234},[235,236],7.62786,47.05901,{"lat":236,"lon":235},[239],{"name":240,"role":35,"phone":10,"phoneExt":10,"email":241},"Sebastian Bigdon, MD","sebastian.bigdon@insel.ch",{"facility":243,"status":45,"city":244,"state":10,"zip":245,"country":246,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"King's College Hospital","London","SE5 9RS","United Kingdom",{"type":51,"coordinates":248},[249,250],-0.12574,51.50853,{"lat":250,"lon":249},[253],{"name":254,"role":35,"phone":10,"phoneExt":10,"email":255},"Gordan Grahovac, MD","gordan.grahovac@nhs.net",{"type":257,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100595042",false,"NCT07027306","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study","Inclusion Criteria:\n\n* Postmenopausal women ≥ 50 years old or men \\> 60 years old\n\n  o Menopause refers to amenorrhea for 1 complete year.\n* Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s).\n\n  * In case of a multilevel fracture, the fracture must be contiguous.\n  * The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma)\n* The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \\[DM\\], and other metabolic bone disorders \\[eg, rickets\u002Fosteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\\]) \\[13-15\\]:\n\n  * A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1\u002F3 radius\n  * Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting.\n* The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:\n\n  * OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \\[STIR\\] sequence)\n  * OF 2: Deformation of one endplate\n  * OF 3: Deformation of one endplate with distinct posterior wall involvement\n  * OF 4: Deformation of both endplates with\u002Fwithout posterior wall involvement\n  * OF 5: Injuries with anterior or posterior tension band failure\n* Ability to provide informed consent according to the EC\u002FIRB defined and approved procedures\n\nExclusion Criteria:\n\n* Patients with spinal tumors\n* Patients with concomitant cervical fractures\n* Patients showing any signs of spinal infections\n* Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with \\> 100 km\u002Fh in cars with airbags, or motor vehicle accident \\> 50 km\u002Fh without airbags, polytrauma\n* Patients with concomitant fracture in the pelvis, upper extremities, and\u002For lower extremities which could affect the main study outcomes (specifically, patient mobility and pain)\n* Patients for whom no FUs are possible\n* Previous instrumented surgery in the affected spine levels\n* Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery\n* Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection\n* Patients who are bedridden before the index fracture\n* Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study","ALL","50 Years",{"count":267,"type":268},648,"ESTIMATED","OBSERVATIONAL","This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics\u002Fhospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \\[MRI\\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \\[CT\\] or MRI).",[272,273],"Osteoporotic Fractures","Osteoporosis","2026-05-11",{"date":276,"type":277},"2026-05-13","ACTUAL",{"date":279,"type":277},"2026-03-19",{"date":281,"type":268},"2030-12-01",{"name":5,"class":6},15]