Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide. — Day 1
  Either the surgeon assists the entire procedure using the device and the patient is registered as "success", or the device is not suitable and cannot be used and the patient is registered as " failure ". Partial use is also considered a failure of the procedure.

Trial sites (1)

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