Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection
Recruitment Status: Recruiting
Start Date: September 12, 2022
End Date: December 31, 2030
Alix Frischknecht, M.sc.
Inclusion Criteria:
- Age 18 years and older
- Initial pathologically confirmed diagnosis of primary oral squamous cell carcinoma located in mucosa and/or mandible
- Undergoing primary curative treatment with segmental resection of the mandible ≥4 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)
- Signed and dated IRB/EC approved informed consent (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
Exclusion Criteria:
- Tumors affecting the condyle
- Distant OSCC metastasis
- Any other active concomitant malignancy within the last 5 years
- Patients who require neoadjuvant therapy
- Patients under palliative care
- Previous extensive mandibular surgeries (including reconstructions) Intraoperative
exclusion criteria:
- Nonsegmental mandibular defect (eg. box resection/partial resection)
- Segmental mandibular defect of less than 4 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