[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370038":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":331,"collaborators":10,"id":333,"slug":334,"hasResults":335,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":10,"eligibilityCriteria":339,"healthyVolunteers":335,"sex":340,"minAge":341,"maxAge":10,"enrollmentInfo":342,"targetDuration":345,"studyType":346,"phases":10,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},{"fullName":5,"class":6},"AO Innovation Translation Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mandibular Reconstruction",null,"Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care",[13],"Procedure: Surgical Resection and Reconstruction",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Surgical Resection and Reconstruction","One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor\u002Fmandibular resection. It is also known as immediate or primary reconstruction.\n\nSecond stage reconstruction: Osseous reconstruction is performed after the tumor\u002Fmandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.",[9],[21],{"name":22,"affiliation":23,"role":24},"Rüdiger Zimmerer, PD, MD","University of Leipzig","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Maria Medina Giner","CONTACT","0795456120","maria.medinaginer@aofoundation.org",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},"Marco Minoia, PhD","marco.minoia@aofoundation.org",[35,54,68,88,100,115,132,146,160,174,188,202,216,231,248,264,283,299,315],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Florida College of Medicine","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-81.65565,30.33218,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":52,"phoneExt":10,"email":53},"Rui Fernandes, Prof","+1 904 244 3901","Rui.Fernandes@jax.ufl.edu",{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"University of Illinois Chicago","Chicago","Illinois","60612",{"type":44,"coordinates":60},[61,62],-87.65005,41.85003,{"lat":62,"lon":61},[65],{"name":66,"role":28,"phone":10,"phoneExt":10,"email":67},"Nicolas Callahan, MD","ncall@uic.edu",{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Northwell Health Cancer Institute","NOT_YET_RECRUITING","New Hyde Park","New York","11042",{"type":44,"coordinates":75},[76,77],-73.68791,40.7351,{"lat":77,"lon":76},[80,84,85],{"name":81,"role":28,"phone":82,"phoneExt":10,"email":83},"Brett Miles","6462846215","bmiles4@northwell.edu",{"name":81,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":86,"role":87,"phone":10,"phoneExt":10,"email":10},"Danielle Scarola","SUB_INVESTIGATOR",{"facility":89,"status":37,"city":72,"state":72,"zip":90,"country":41,"countryCode":42,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Mount Sinai Hospital","10029",{"type":44,"coordinates":92},[93,94],-74.00597,40.71427,{"lat":94,"lon":93},[97],{"name":98,"role":28,"phone":10,"phoneExt":10,"email":99},"Mohammed Khan, MD","mohemmed.khan@mountsinai.org",{"facility":101,"status":37,"city":102,"state":103,"zip":104,"country":41,"countryCode":42,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"John Peter Smith Health Network","Fort Worth","Texas","76104",{"type":44,"coordinates":106},[107,108],-97.32085,32.72541,{"lat":108,"lon":107},[111],{"name":112,"role":28,"phone":113,"phoneExt":10,"email":114},"Roderick Kim, MD","+1 817-702-6979","roderickykim@gmail.com",{"facility":116,"status":37,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Universitätsklinikum Tübingen","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":44,"coordinates":123},[124,125],9.05222,48.52266,{"lat":125,"lon":124},[128],{"name":129,"role":28,"phone":130,"phoneExt":10,"email":131},"Andreas Naros, MD","+49 7071 2986174","andreas.naros@med.uni-tuebingen.de",{"facility":133,"status":37,"city":134,"state":10,"zip":135,"country":120,"countryCode":121,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"University Hospital RWTH Aachen","Aachen","52074",{"type":44,"coordinates":137},[138,139],6.08342,50.77664,{"lat":139,"lon":138},[142],{"name":143,"role":28,"phone":144,"phoneExt":10,"email":145},"Ali Modabber, Prof","+49 241 80 88258","Amodabber@ukaachen.de",{"facility":147,"status":37,"city":148,"state":10,"zip":149,"country":120,"countryCode":121,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"University Hospital Charité","Berlin","13353",{"type":44,"coordinates":151},[152,153],13.41053,52.52437,{"lat":153,"lon":152},[156],{"name":157,"role":28,"phone":158,"phoneExt":10,"email":159},"Max Heiland, Prof","+49 450 655 270","Max.Heiland@charite.de",{"facility":161,"status":37,"city":162,"state":10,"zip":163,"country":120,"countryCode":121,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Hannover Medical School","Hanover","30625",{"type":44,"coordinates":165},[166,167],9.73322,52.37052,{"lat":167,"lon":166},[170],{"name":171,"role":28,"phone":172,"phoneExt":10,"email":173},"Philippe Korn, PD, MD","+49 511 532 4879","korn.philippe@mh-hannover.de",{"facility":175,"status":37,"city":176,"state":10,"zip":177,"country":120,"countryCode":121,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"type":44,"coordinates":179},[180,181],8.69079,49.40768,{"lat":181,"lon":180},[184],{"name":185,"role":28,"phone":186,"phoneExt":10,"email":187},"Christian Freudlsperger, Prof","+49 6221 56 34444","Christian.Freudlsperger@med.uni-heidelberg.de",{"facility":189,"status":37,"city":190,"state":10,"zip":191,"country":120,"countryCode":121,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"University Hospital Leipzig","Leipzig","04103",{"type":44,"coordinates":193},[194,195],12.37129,51.33962,{"lat":195,"lon":194},[198],{"name":199,"role":28,"phone":200,"phoneExt":10,"email":201},"Tabea Pankow, PD, MD","+ 49 3419721863","tabea.pankow@medizin.uni-leipzig.de",{"facility":203,"status":37,"city":204,"state":10,"zip":205,"country":120,"countryCode":121,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Klinikum der LMU München","Munich","80337",{"type":44,"coordinates":207},[208,209],11.57549,48.13743,{"lat":209,"lon":208},[212],{"name":213,"role":28,"phone":214,"phoneExt":10,"email":215},"Wenko Smolka, PD, MD","+49 440054458","Wenko.Smolka@med.lmu.de",{"facility":217,"status":37,"city":218,"state":10,"zip":219,"country":120,"countryCode":121,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"University Hospital Ulm","Ulm","89081",{"type":44,"coordinates":221},[222,223],9.99155,48.39841,{"lat":223,"lon":222},[226,230],{"name":227,"role":28,"phone":228,"phoneExt":10,"email":229},"Marcel Ebeling","+49 731 1710 35806","marcelebeling@uni-ulm.de",{"name":227,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":232,"status":70,"city":233,"state":10,"zip":234,"country":235,"countryCode":236,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Shimane University","Izumo","693-0001","Japan","JP",{"type":44,"coordinates":238},[239,240],132.76667,35.36667,{"lat":240,"lon":239},[243,247],{"name":244,"role":28,"phone":245,"phoneExt":10,"email":246},"Takahiro Kanno","+81 90 5086 2506","tkanno@med.shimane-u.ac.jp",{"name":244,"role":24,"phone":10,"phoneExt":10,"email":10},{"facility":249,"status":37,"city":250,"state":10,"zip":251,"country":252,"countryCode":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Erasmus University Medical Centre","Rotterdam","3015 GD","Netherlands","NL",{"type":44,"coordinates":255},[256,257],4.47917,51.9225,{"lat":257,"lon":256},[260],{"name":261,"role":28,"phone":262,"phoneExt":10,"email":263},"Eppo Wolvius, Prof","+31 6 22 48 77 81","E.Wolvius@erasmusmc.nl",{"facility":265,"status":70,"city":266,"state":10,"zip":267,"country":268,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Luz Hospital","Lisbon","1500-650","Portugal","PT",{"type":44,"coordinates":271},[272,273],-9.1498,38.72509,{"lat":273,"lon":272},[276,280,281],{"name":277,"role":28,"phone":278,"phoneExt":10,"email":279},"Alberto Pereira","+351 917593318","alberto.rocha.pereira@hospitaldaluz.pt",{"name":277,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":282,"role":87,"phone":10,"phoneExt":10,"email":10},"Henrique Messias",{"facility":284,"status":37,"city":285,"state":10,"zip":286,"country":287,"countryCode":288,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"12 de Octubre","Madrid","28041","Spain","ES",{"type":44,"coordinates":290},[291,292],-3.70256,40.4165,{"lat":292,"lon":291},[295],{"name":296,"role":28,"phone":297,"phoneExt":10,"email":298},"Maria Mejía Nieto, MD","+34 687 083 530","Mmejianieto@hotmail.com",{"facility":300,"status":37,"city":301,"state":10,"zip":302,"country":303,"countryCode":304,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Uppsala University Hospital","Uppsala","75185","Sweden","SE",{"type":44,"coordinates":306},[307,308],17.63889,59.85882,{"lat":308,"lon":307},[311],{"name":312,"role":28,"phone":313,"phoneExt":10,"email":314},"Andreas Thor, Prof","+46 18 6116450","Andreas.Thor@akademiska.se",{"facility":316,"status":37,"city":317,"state":10,"zip":318,"country":319,"countryCode":320,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"University Hospital Basel","Basel","4031","Switzerland","CH",{"type":44,"coordinates":322},[323,324],7.57327,47.55839,{"lat":324,"lon":323},[327],{"name":328,"role":28,"phone":329,"phoneExt":10,"email":330},"Florian Thieringer, MD","+41 612 657 344","Florian.Thieringer@usb.ch",{"type":332,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100370038","registry-to-collect-data-on-patients-undergoing-segmental-mandibular-defect-reconstruction-following-oral-squamous-cell-carcinoma-resection-and-drugs-induced-osteonecrosis-100370038",false,"NCT04098146","Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis","A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis","Inclusion Criteria:\n\n* The study includes patients with an initial pathological\u002Fhistologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.\n* Age 18 years and older\n* Bisphosphonate related osteonecrosis of the mandible\n* Immunomodulatory drugs induced mandibular osteonecrosis\n* Patients presented with ameloblastoma affecting the mandible\n* Patients presented with osteosarcomas of the mandible\n* Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney\n* Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm\n* Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach\n* Informed consent obtained, ie:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB\u002FEC approved ICF OR\n  * Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide to provide independent written informed consent\n\nExclusion Criteria:\n\n* Tumors affecting the condyle\n* Patients under palliative care\n* Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures\n\nIntraoperative exclusion criteria:\n\n* Nonsegmental mandibular defect (eg. box resection\u002Fpartial resection)\n* Segmental mandibular defect of less than 2 cm\n* Mandibular defects extending beyond the sigmoid notch into the condyles\n\nAdditional exclusion criterion:\n\n• No osseous reconstruction with autologous bone performed within 18 months from resection","ALL","18 Years",{"count":343,"type":344},300,"ESTIMATED","2 Years","OBSERVATIONAL","Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.",[9,349],"Segmental Mandibular Defects",[351,352,353,354],"Mandibular osteotomy","Free bone flap","Reconstructive surgical procedure","Adjuvant Irradiation \u002F Chemotherapy","2025-08-28",{"date":357,"type":358},"2025-09-04","ACTUAL",{"date":360,"type":358},"2022-09-12",{"date":362,"type":344},"2030-12-31",{"name":5,"class":6},19]