Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Mandibular Reconstruction Clinical Trial

— FIBUMAND  

Official title:

Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238076
• Other study ID #: RC31/17/0347
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: April 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Toulouse
• Contact: Frédéric LAUWERS, MD
• Phone: 33-561779543
• Email: lauwers.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: April 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mandibular Reconstruction

Intervention

Device:
• Universal surgical device FIBUMAND
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Time of surgical procedure	It is timed (in minutes) during the procedure and relative to the total duration of the intervention.	Day 1
Secondary	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	Day 1
Secondary	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.	From 6 to 8 weeks