[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370038":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":45,"armGroups":46,"interventions":52,"overallOfficials":58,"centralContacts":63,"locations":72,"responsibleParty":369,"collaborators":40,"id":371,"slug":40,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":40,"eligibilityCriteria":376,"healthyVolunteers":372,"sex":377,"minAge":378,"maxAge":40,"enrollmentInfo":379,"targetDuration":382,"studyType":383,"phases":40,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"AO Innovation Translation Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":40},[9,13,16,19,23,27,30,34,37],{"measure":10,"description":11,"timeFrame":12},"Demographics","Demographics (year of birth, height in cm and weight in kilogram, race)","Baseline until resection surgery approximately 4 weeks",{"measure":14,"description":15,"timeFrame":12},"Comorbidities","Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates",{"measure":17,"description":18,"timeFrame":12},"Nicotine consumption","Current and previous nicotine use will be collected:\n\n* Number of years\n* Time (years) since stopped using (if applicable)\n* Amount of cigarettes\u002Fday",{"measure":20,"description":21,"timeFrame":22},"Patient reported outcome: Oral Health Impact Profile (OHIP)","Change in the OHIP over the follow-up period.\n\nThe Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: \"Very often\", \"Fairly often\", \"Occasionally\", \"Hardly ever\" and \"Never\". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.","Baseline\u002F 3months\u002F 6 months\u002F 12 months\u002F 18 months\u002F 24 months",{"measure":24,"description":25,"timeFrame":26},"Difference of tumor locations of the oral squamous cell cancer","Oral squamous cell carcinoma locations acoording to follwoing regions:\n\n* Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth\n* Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth\n* Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions\n* Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue","Baseline until resection surgery ( approximately 4 weeks)",{"measure":28,"description":29,"timeFrame":26},"Difference of tumor staging according to the TNM system","Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system.\n\nIn the TNM system the \"T\" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size.\n\nThe main tumor is usually called the primary tumor. The \"N\" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The \"M\" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis.",{"measure":31,"description":32,"timeFrame":33},"Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages","* Duration of surgery (skin to skin) in minutes\n* Length of hospital stay in days\n* Date of osseous reconstruction (if different from resection surgery) in days","Day of resection surgery until day of reconstruction surgery up to 18 months",{"measure":35,"description":36,"timeFrame":33},"Difference of surgical procedures of osseous reconstruction","* Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible\n* Type of bone donor\u002F bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)",{"measure":38,"description":39,"timeFrame":33},"Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used","* Use of virtual surgical planning (VSP) for resection: Yes\u002FNo.\n* Only virtual planning and simulation of resection (no 3D printing):Yes\u002FNo.\n* 3D-printed biomodels: Yes\u002FNo",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"CASE_CONTROL","PROSPECTIVE","Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic\u002Finfected tissue, all of whom require mandibular reconstruction.\n\nThe follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and\u002For reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.\n\nData collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.\n\nDepending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.","Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.",[47],{"label":48,"type":40,"description":49,"interventionNames":50},"Mandibular Reconstruction","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",[51],"Procedure: Surgical Resection and Reconstruction",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":40},"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.",[48],[59],{"name":60,"affiliation":61,"role":62},"Rüdiger Zimmerer, PD, MD","University of Leipzig","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":40,"email":68},"Maria Medina Giner","CONTACT","0795456120","maria.medinaginer@aofoundation.org",{"name":70,"role":66,"phone":40,"phoneExt":40,"email":71},"Marco Minoia, PhD","marco.minoia@aofoundation.org",[73,92,106,126,138,153,170,184,198,212,226,240,254,269,286,302,321,337,353],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"University of Florida College of Medicine","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-81.65565,30.33218,{"lat":85,"lon":84},[88],{"name":89,"role":66,"phone":90,"phoneExt":40,"email":91},"Rui Fernandes, Prof","+1 904 244 3901","Rui.Fernandes@jax.ufl.edu",{"facility":93,"status":75,"city":94,"state":95,"zip":96,"country":79,"countryCode":80,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University of Illinois Chicago","Chicago","Illinois","60612",{"type":82,"coordinates":98},[99,100],-87.65005,41.85003,{"lat":100,"lon":99},[103],{"name":104,"role":66,"phone":40,"phoneExt":40,"email":105},"Nicolas Callahan, MD","ncall@uic.edu",{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":79,"countryCode":80,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Northwell Health Cancer Institute","NOT_YET_RECRUITING","New Hyde Park","New York","11042",{"type":82,"coordinates":113},[114,115],-73.68791,40.7351,{"lat":115,"lon":114},[118,122,123],{"name":119,"role":66,"phone":120,"phoneExt":40,"email":121},"Brett Miles","6462846215","bmiles4@northwell.edu",{"name":119,"role":62,"phone":40,"phoneExt":40,"email":40},{"name":124,"role":125,"phone":40,"phoneExt":40,"email":40},"Danielle Scarola","SUB_INVESTIGATOR",{"facility":127,"status":75,"city":110,"state":110,"zip":128,"country":79,"countryCode":80,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Mount Sinai Hospital","10029",{"type":82,"coordinates":130},[131,132],-74.00597,40.71427,{"lat":132,"lon":131},[135],{"name":136,"role":66,"phone":40,"phoneExt":40,"email":137},"Mohammed Khan, MD","mohemmed.khan@mountsinai.org",{"facility":139,"status":75,"city":140,"state":141,"zip":142,"country":79,"countryCode":80,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"John Peter Smith Health Network","Fort Worth","Texas","76104",{"type":82,"coordinates":144},[145,146],-97.32085,32.72541,{"lat":146,"lon":145},[149],{"name":150,"role":66,"phone":151,"phoneExt":40,"email":152},"Roderick Kim, MD","+1 817-702-6979","roderickykim@gmail.com",{"facility":154,"status":75,"city":155,"state":156,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Universitätsklinikum Tübingen","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":82,"coordinates":161},[162,163],9.05222,48.52266,{"lat":163,"lon":162},[166],{"name":167,"role":66,"phone":168,"phoneExt":40,"email":169},"Andreas Naros, MD","+49 7071 2986174","andreas.naros@med.uni-tuebingen.de",{"facility":171,"status":75,"city":172,"state":40,"zip":173,"country":158,"countryCode":159,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"University Hospital RWTH Aachen","Aachen","52074",{"type":82,"coordinates":175},[176,177],6.08342,50.77664,{"lat":177,"lon":176},[180],{"name":181,"role":66,"phone":182,"phoneExt":40,"email":183},"Ali Modabber, Prof","+49 241 80 88258","Amodabber@ukaachen.de",{"facility":185,"status":75,"city":186,"state":40,"zip":187,"country":158,"countryCode":159,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University Hospital Charité","Berlin","13353",{"type":82,"coordinates":189},[190,191],13.41053,52.52437,{"lat":191,"lon":190},[194],{"name":195,"role":66,"phone":196,"phoneExt":40,"email":197},"Max Heiland, Prof","+49 450 655 270","Max.Heiland@charite.de",{"facility":199,"status":75,"city":200,"state":40,"zip":201,"country":158,"countryCode":159,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Hannover Medical School","Hanover","30625",{"type":82,"coordinates":203},[204,205],9.73322,52.37052,{"lat":205,"lon":204},[208],{"name":209,"role":66,"phone":210,"phoneExt":40,"email":211},"Philippe Korn, PD, MD","+49 511 532 4879","korn.philippe@mh-hannover.de",{"facility":213,"status":75,"city":214,"state":40,"zip":215,"country":158,"countryCode":159,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"type":82,"coordinates":217},[218,219],8.69079,49.40768,{"lat":219,"lon":218},[222],{"name":223,"role":66,"phone":224,"phoneExt":40,"email":225},"Christian Freudlsperger, Prof","+49 6221 56 34444","Christian.Freudlsperger@med.uni-heidelberg.de",{"facility":227,"status":75,"city":228,"state":40,"zip":229,"country":158,"countryCode":159,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"University Hospital Leipzig","Leipzig","04103",{"type":82,"coordinates":231},[232,233],12.37129,51.33962,{"lat":233,"lon":232},[236],{"name":237,"role":66,"phone":238,"phoneExt":40,"email":239},"Tabea Pankow, PD, MD","+ 49 3419721863","tabea.pankow@medizin.uni-leipzig.de",{"facility":241,"status":75,"city":242,"state":40,"zip":243,"country":158,"countryCode":159,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Klinikum der LMU München","Munich","80337",{"type":82,"coordinates":245},[246,247],11.57549,48.13743,{"lat":247,"lon":246},[250],{"name":251,"role":66,"phone":252,"phoneExt":40,"email":253},"Wenko Smolka, PD, MD","+49 440054458","Wenko.Smolka@med.lmu.de",{"facility":255,"status":75,"city":256,"state":40,"zip":257,"country":158,"countryCode":159,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"University Hospital Ulm","Ulm","89081",{"type":82,"coordinates":259},[260,261],9.99155,48.39841,{"lat":261,"lon":260},[264,268],{"name":265,"role":66,"phone":266,"phoneExt":40,"email":267},"Marcel Ebeling","+49 731 1710 35806","marcelebeling@uni-ulm.de",{"name":265,"role":62,"phone":40,"phoneExt":40,"email":40},{"facility":270,"status":108,"city":271,"state":40,"zip":272,"country":273,"countryCode":274,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Shimane University","Izumo","693-0001","Japan","JP",{"type":82,"coordinates":276},[277,278],132.76667,35.36667,{"lat":278,"lon":277},[281,285],{"name":282,"role":66,"phone":283,"phoneExt":40,"email":284},"Takahiro Kanno","+81 90 5086 2506","tkanno@med.shimane-u.ac.jp",{"name":282,"role":62,"phone":40,"phoneExt":40,"email":40},{"facility":287,"status":75,"city":288,"state":40,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Erasmus University Medical Centre","Rotterdam","3015 GD","Netherlands","NL",{"type":82,"coordinates":293},[294,295],4.47917,51.9225,{"lat":295,"lon":294},[298],{"name":299,"role":66,"phone":300,"phoneExt":40,"email":301},"Eppo Wolvius, Prof","+31 6 22 48 77 81","E.Wolvius@erasmusmc.nl",{"facility":303,"status":108,"city":304,"state":40,"zip":305,"country":306,"countryCode":307,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Luz Hospital","Lisbon","1500-650","Portugal","PT",{"type":82,"coordinates":309},[310,311],-9.1498,38.72509,{"lat":311,"lon":310},[314,318,319],{"name":315,"role":66,"phone":316,"phoneExt":40,"email":317},"Alberto Pereira","+351 917593318","alberto.rocha.pereira@hospitaldaluz.pt",{"name":315,"role":62,"phone":40,"phoneExt":40,"email":40},{"name":320,"role":125,"phone":40,"phoneExt":40,"email":40},"Henrique Messias",{"facility":322,"status":75,"city":323,"state":40,"zip":324,"country":325,"countryCode":326,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"12 de Octubre","Madrid","28041","Spain","ES",{"type":82,"coordinates":328},[329,330],-3.70256,40.4165,{"lat":330,"lon":329},[333],{"name":334,"role":66,"phone":335,"phoneExt":40,"email":336},"Maria Mejía Nieto, MD","+34 687 083 530","Mmejianieto@hotmail.com",{"facility":338,"status":75,"city":339,"state":40,"zip":340,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Uppsala University Hospital","Uppsala","75185","Sweden","SE",{"type":82,"coordinates":344},[345,346],17.63889,59.85882,{"lat":346,"lon":345},[349],{"name":350,"role":66,"phone":351,"phoneExt":40,"email":352},"Andreas Thor, Prof","+46 18 6116450","Andreas.Thor@akademiska.se",{"facility":354,"status":75,"city":355,"state":40,"zip":356,"country":357,"countryCode":358,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"University Hospital Basel","Basel","4031","Switzerland","CH",{"type":82,"coordinates":360},[361,362],7.57327,47.55839,{"lat":362,"lon":361},[365],{"name":366,"role":66,"phone":367,"phoneExt":40,"email":368},"Florian Thieringer, MD","+41 612 657 344","Florian.Thieringer@usb.ch",{"type":370,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","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":380,"type":381},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.",[48,386],"Segmental Mandibular Defects",[388,389,390,391],"Mandibular osteotomy","Free bone flap","Reconstructive surgical procedure","Adjuvant Irradiation \u002F Chemotherapy","2025-08-28",{"date":394,"type":395},"2025-09-04","ACTUAL",{"date":397,"type":395},"2022-09-12",{"date":399,"type":381},"2030-12-31",{"name":5,"class":6},19]