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Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Toulouse
NCT06238076 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Universal surgical device FIBUMAND
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Where

1 site
CHU Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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