Overview
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction.
Description
Prospective data will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction.
The 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/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.
Data 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.
Depending 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.
Eligibility
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