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

Conditions

• Mandibular Reconstruction
• Segmental Mandibular Defects

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Surgical Resection and Reconstruction — PROCEDURE
  One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Study Details

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.

Key Dates

Start date

Sep 12, 2022

Status verified

Aug 2025

Primary completion

Jun 30, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Mandibular Reconstruction
  Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care

Primary Outcome Measure

Demographics [ Time Frame: Baseline until resection surgery approximately 4 weeks ]

Central Contacts

• Maria Medina Giner
  0795456120
  [email protected]
• Marco Minoia, PhD
  [email protected]

Locations (5)

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