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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Alice PREVOST, MD
prevost.a@chu-toulouse.fr
+335 61 77 95 43
Backup
Frédéric LAUWERS, MD
lauwers.f@chu-toulouse.fr
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2026-05
Participants
Target number of participants: 19
Treatments
Experimental: Group experimental
The patients included in the study and admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction will benefit from a surgery assisted with the universal surgical device FIBUMAND.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov