[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595042":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":270,"collaborators":10,"id":272,"slug":273,"hasResults":274,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":10,"eligibilityCriteria":278,"healthyVolunteers":274,"sex":279,"minAge":280,"maxAge":10,"enrollmentInfo":281,"targetDuration":10,"studyType":284,"phases":10,"briefSummary":285,"conditions":286,"keywords":10,"overallStatus":196,"whyStopped":10,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"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",[43,61,75,90,105,120,135,150,164,179,194,210,225,240,255],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of California San Francisco (USCF) Department of Orthopaedic Surgery","NOT_YET_RECRUITING","San Francisco","California","94143-0728","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},[58],{"name":59,"role":35,"phone":10,"phoneExt":10,"email":60},"Ashraf El Naga, MD","ashraf.elnaga@ucsf.edu",{"facility":62,"status":45,"city":63,"state":64,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107-4216",{"type":52,"coordinates":67},[68,69],-75.16362,39.95238,{"lat":69,"lon":68},[72],{"name":73,"role":35,"phone":10,"phoneExt":10,"email":74},"Alexander R Vaccaro, MD","alex.vaccaro@rothmaninstitute.com",{"facility":76,"status":45,"city":77,"state":10,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Sanatorio Güemes","Buenos Aires","1240","Argentina","AR",{"type":52,"coordinates":82},[83,84],-58.37723,-34.61315,{"lat":84,"lon":83},[87],{"name":88,"role":35,"phone":10,"phoneExt":10,"email":89},"Guillermo Ricciardi, MD","guillermoricciardi@gmail.com",{"facility":91,"status":45,"city":92,"state":10,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Cajuru University Hospital","Curitiba","80050-50","Brazil","BR",{"type":52,"coordinates":97},[98,99],-49.27306,-25.42778,{"lat":99,"lon":98},[102],{"name":103,"role":35,"phone":10,"phoneExt":10,"email":104},"Emiliano Vialle, MD","evialle@hotmail.com",{"facility":106,"status":45,"city":107,"state":10,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Department of Orthopedic Surgery, Clinica Alemana de Santiago","Santiago","5951","Chile","CL",{"type":52,"coordinates":112},[113,114],-70.64827,-33.45694,{"lat":114,"lon":113},[117],{"name":118,"role":35,"phone":10,"phoneExt":10,"email":119},"Ratko Yurac, MD","ryurac@gmail.com",{"facility":121,"status":45,"city":122,"state":10,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine","Asyut","71526","Egypt","EG",{"type":52,"coordinates":127},[128,129],31.18368,27.18096,{"lat":129,"lon":128},[132],{"name":133,"role":35,"phone":10,"phoneExt":10,"email":134},"Mohammad El-Sharkawi, MD","sharkoran@aun.edu.eg",{"facility":136,"status":45,"city":137,"state":10,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Tampere University Hospital","Tampere","33521","Finland","FI",{"type":52,"coordinates":142},[143,144],23.78712,61.49911,{"lat":144,"lon":143},[147],{"name":148,"role":35,"phone":10,"phoneExt":10,"email":149},"Marko Neva, MD","marko_neva@yahoo.com",{"facility":151,"status":45,"city":152,"state":10,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien","Erlangen","91054","Germany","DE",{"type":52,"coordinates":157},[158,159],11.00783,49.59099,{"lat":159,"lon":158},[162],{"name":29,"role":35,"phone":10,"phoneExt":10,"email":163},"Klaus.Schnake@waldkrankenhaus.de",{"facility":165,"status":45,"city":166,"state":10,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"PGIMER - Postgraduate Institute of Medical Education and Research","Chandigarh","160 012","India","IN",{"type":52,"coordinates":171},[172,173],76.7884,30.73629,{"lat":173,"lon":172},[176],{"name":177,"role":35,"phone":10,"phoneExt":10,"email":178},"Vishal Kumar, MD","drkumarvishal@gmail.com",{"facility":180,"status":45,"city":181,"state":10,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Dokkyo Medical University Hospital","Tochigi","321-0293","Japan","JP",{"type":52,"coordinates":186},[187,188],139.73333,36.38333,{"lat":188,"lon":187},[191],{"name":192,"role":35,"phone":10,"phoneExt":10,"email":193},"Masahito Takahata, MD","takahiroshm@yahoo.co.jp",{"facility":195,"status":196,"city":197,"state":10,"zip":198,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Island Hospital Spine Centre","RECRUITING","George Town","10450","Malaysia","MY",{"type":52,"coordinates":202},[203,204],100.33543,5.41123,{"lat":204,"lon":203},[207],{"name":208,"role":35,"phone":10,"phoneExt":10,"email":209},"Kim Soon Oh, MD","ohkimsoon@utar.edu.my",{"facility":211,"status":196,"city":212,"state":10,"zip":213,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Spiatlul Clinic De Urgenta, \"Profesor Doctor Nicolae Oblu\"","Iași","700309","Romania","RO",{"type":52,"coordinates":217},[218,219],27.6,47.16667,{"lat":219,"lon":218},[222],{"name":223,"role":35,"phone":10,"phoneExt":10,"email":224},"Eugen Cezar Popescu, MD","ciepopescu@yahoo.com",{"facility":226,"status":196,"city":227,"state":10,"zip":228,"country":229,"countryCode":230,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Security Force Hospital","Riyāḑ","11564","Saudi Arabia","SA",{"type":52,"coordinates":232},[233,234],40.3,20.1,{"lat":234,"lon":233},[237],{"name":238,"role":35,"phone":10,"phoneExt":10,"email":239},"Ahmed Alzahrani, MD","ahmed_alzahrani_4@hotmail.com",{"facility":241,"status":45,"city":242,"state":10,"zip":243,"country":244,"countryCode":245,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Spital Emmental - Orthopädie Sonnenhof","Burgdorf","3400","Switzerland","CH",{"type":52,"coordinates":247},[248,249],7.62786,47.05901,{"lat":249,"lon":248},[252],{"name":253,"role":35,"phone":10,"phoneExt":10,"email":254},"Sebastian Bigdon, MD","sebastian.bigdon@insel.ch",{"facility":256,"status":45,"city":257,"state":10,"zip":258,"country":259,"countryCode":260,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"King's College Hospital","London","SE5 9RS","United Kingdom","UK",{"type":52,"coordinates":262},[263,264],-0.12574,51.50853,{"lat":264,"lon":263},[267],{"name":268,"role":35,"phone":10,"phoneExt":10,"email":269},"Gordan Grahovac, MD","gordan.grahovac@nhs.net",{"type":271,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100595042","the-osteoporotic-fracture-classification-based-scoring-system-for-treatment-decision-in-thoracolumbar-osteoporotic-fractures-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":282,"type":283},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).",[287,288],"Osteoporotic Fractures","Osteoporosis","2026-05-11",{"date":291,"type":292},"2026-05-13","ACTUAL",{"date":294,"type":292},"2026-03-19",{"date":296,"type":283},"2030-12-01",{"name":5,"class":6},15]