RecruitingNot ApplicableNCT06238076

Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

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


Sponsor

University Hospital, Toulouse

Enrollment

19 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Universal surgical device FIBUMAND for people with mandibular reconstruction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUniversal 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

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NCT06238076


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