Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
- Conditions
- Mandibular Reconstruction
- Interventions
- Device: Universal surgical device FIBUMAND
- Registration Number
- NCT06238076
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 19
- 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
- Lateral mandibular reconstruction without symphysis reconstruction
- Legally incompetent
- Inclusion in another protocol of research , involving mandibular reconstruction
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group experimental Universal surgical device FIBUMAND 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 obtainedPost-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.Time of surgical procedure Day 1 It is timed (in minutes) during the procedure and relative to the total duration of the intervention.
Trial Locations
- Locations (1)
CHU Toulouse
🇫🇷Toulouse, France