NCT06238076

Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity. Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide. The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.

Conditions

• Mandibular Reconstruction

Interventions

Type	Name	Description
DEVICE	Universal surgical device FIBUMAND	This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

Timeline

• Start date: 2024-03-28
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2024-02-02
• Last updated: 2025-03-17

Locations

1 site across 1 country: France