Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
ConditionMandibular Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
Qualifiers
Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment
Patients insured under the French social security system
Free and informed consent
Disqualifiers
Lateral mandibular reconstruction without symphysis reconstruction
Legally incompetent
Inclusion in another protocol of research , involving mandibular reconstruction
Pregnant or breastfeeding women
Trial design
Treatments tested in this trial
- Universal surgical device FIBUMAND
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov