Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Universal surgical device FIBUMAND.
- Who it may be relevant to
- Registry conditions: Mandibular Reconstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
Overview
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.
Interventions
- Device Universal surgical device FIBUMAND
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.
Primary outcome measures
- Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide. [Time frame: Day 1]
Secondary outcome measures (3)
- Time of surgical procedure [Time frame: Day 1]
- Qualitative assessment of the device by the surgeon [Time frame: Day 1]
- Post-operative quality of life [Time frame: From 6 to 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Toulouse — Toulouse
Identifiers
NCT: NCT06238076 · RC31/17/0347