Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection

Mandibular Reconstruction Clinical Trial

Official title: International, Multicenter, Prospective Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction (SMDR) Following Oral Squamous Cell Carcinoma (OSSC) Resection

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mandibular Reconstruction
• Squamous Cell Carcinoma of Head and Neck

• NCT number: NCT04098146
• Study type: Observational [Patient Registry]
• Source: AO Innovation Translation Center
• Contact: Felix Thomas, PhD
• Phone: + 41 79 671 47 98
• Email: felix.thomas@aofoundation.org
• Status: Recruiting
• Start date: September 12, 2022
• Completion date: December 31, 2028