Mandibular Reconstruction
Conditions
Keywords
Mandible, Mandibular Reconstruction, Computer-Aided Design, Fibular free flap, Computer Assisted three dimensional imaging, Surgical equipment
Brief 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.
Interventions
DEVICEUniversal surgical device FIBUMAND
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility pilot study, monocentric, non-comparative
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide. | Day 1 | Either the surgeon assists the entire procedure using the device and the patient is registered as success, or the device is not suitable and cannot be used and the patient is registered as failure . Partial use is also considered a failure of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of surgical procedure | Day 1 | It is timed (in minutes) during the procedure and relative to the total duration of the intervention. |
| Qualitative assessment of the device by the surgeon | Day 1 | Evaluation of the general appreciation according a 4-point scale (very unsatisfactory / unsatisfactory / satisfactory / excellent) about the: * The positioning and fixing of the guide, * Performing osteotomies, * The use of the meter, * The congruence of the bone surfaces, * The use of the plate shaper, * Fibular osteosynthesis, * The mandibular reconstruction obtained |
| Post-operative quality of life | From 6 to 8 weeks | The patient's postoperative quality of life will be assessed by the University of Washington Quality of Life Questionnaire (UW-QOL) version 4.0. UW-QOL questionnaire consists of 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them. There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL.The whole questionnaire focuses on current patient health and quality of life within the past 7 days. |
Countries
France
Contacts
Primary ContactAlice PREVOST, MD
Backup ContactFrédéric LAUWERS, MD
Outcome results
None listed