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Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
Sponsor: University Hospital, Toulouse
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
Conditions
Interventions
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