A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
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.
• The study includes patients with an initial pathological/histologic 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.
• Age 18 years and older
• Bisphosphonate related osteonecrosis of the mandible
• Immunomodulatory drugs induced mandibular osteonecrosis
• Patients presented with ameloblastoma affecting the mandible
• Patients presented with osteosarcomas of the mandible
• Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney
• Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm
• Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach
• Informed consent obtained, ie:
‣ Ability to understand the content of the patient information/ICF
⁃ Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR
⁃ Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent