Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Recruiting now · Not applicable

Conditions studied: Mandibular Reconstruction

In brief

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.

Key facts

Study ID

NCT06238076

Run by

University Hospital, Toulouse

People needed

19

Starts

2024-03-28

Expected to finish

2026-05-01

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• CHU Toulouse — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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