Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

Inclusion Criteria:

• The study includes patients with an initial pathological/histologic diagnosis ofmandibular involvement by oral tumors (such as OSCC, osteosarcoma, andameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, andmandibular lesions from metastatic conditions originating from other sites includinglung, 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 areindicated 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 accordingto the registry plan (RP) o Signed and dated IRB/EC approved ICF OR

• Written consent provided according to the IRB/EC defined and approvedprocedures for patients who are not able to provide to provide independentwritten informed consent

Exclusion Criteria:

• Tumors affecting the condyle

• Patients under palliative care

• Previous extensive mandibular surgeries (including reconstructions, e.g., TMJreplacement) that may potentially confound the outcome measures

Intraoperative exclusion criteria:

• Nonsegmental mandibular defect (eg. box resection/partial resection)

• Segmental mandibular defect of less than 2 cm

• Mandibular defects extending beyond the sigmoid notch into the condyles

Additional exclusion criterion:

• No osseous reconstruction with autologous bone performed within 18 months from resection