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RECRUITING
NCT06238076
NA

Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2024-03-28

Completion Date

2026-05

Last Updated

2025-03-17

Healthy Volunteers

No

Interventions

DEVICE

Universal surgical device FIBUMAND

This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

Locations (1)

CHU Toulouse

Toulouse, France