Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
ConditionMandibular Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lateral mandibular reconstruction without symphysis reconstruction
Legally incompetent
Inclusion in another protocol of research , involving mandibular reconstruction
Pregnant or breastfeeding women
Trial design
Design model
Single group
Treatments tested in this trial
Universal surgical device FIBUMAND
DeviceThis device is made of biocompatible resin for type IIa medical devices with a 3D printer.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Group experimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide.
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.
Time frame
Day 1Secondary outcomes
1
Time of surgical procedure
It is timed (in minutes) during the procedure and relative to the total duration of the intervention.
Time frame
Day 12
Qualitative assessment of the device by the surgeon
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
Time frame
Day 13
Post-operative quality of life
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 frame
From 6 to 8 weeksSponsors and contacts
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Source ClinicalTrials.gov