[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"segmental-mandibular-defects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:segmental-mandibular-defects":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":18,"type":19},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.",[24,25],"Mandibular Reconstruction","Segmental Mandibular Defects",[27,28,29,30],"Mandibular osteotomy","Free bone flap","Reconstructive surgical procedure","Adjuvant Irradiation \u002F Chemotherapy","RECRUITING","2025-08-28",{"date":34,"type":35},"2025-09-04","ACTUAL",{"date":37,"type":35},"2022-09-12",{"date":39,"type":19},"2030-12-31",{"name":41,"class":42},"AO Innovation Translation Center","OTHER",19,""]