Evaluation of an Universal Surgical Device for Mandibular Reconstruction. (FIBUMAND)

Toulouse University Hospital

Status: Enrolling

Conditions: Mandibular Reconstruction

Treatments: Device: Universal surgical device FIBUMAND

Study type: Interventional

Funder types: Other

Identifiers

NCT06238076

RC31/17/0347

Details and patient eligibility

About

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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Lateral mandibular reconstruction without symphysis reconstruction
• Legally incompetent
• Inclusion in another protocol of research , involving mandibular reconstruction
• Pregnant or breastfeeding women

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

Group experimental

Experimental group

Description:

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.

Treatment:

Device: Universal surgical device FIBUMAND