Evaluation of an Universal Surgical Device for Mandibular Reconstruction. (FIBUMAND)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mandibular Reconstruction
• Intervention / Treatment: Device: Universal surgical device FIBUMAND

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice PREVOST, MD; Phone Number: +335 61 77 95 43; Email: prevost.a@chu-toulouse.fr
• Study Contact Backup: Name: Frédéric LAUWERS, MD; Email: lauwers.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • CHU Toulouse
    • Contact: Alice PREVOST, MD; Email: prevost.a@chu-toulouse.fr
    • Contact: Frédéric LAUWERS, MD
    • Contact: Alice PREVOST, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group experimental; 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.	Device: Universal surgical device FIBUMAND; This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of surgical procedure	It is timed (in minutes) during the procedure and relative to the total duration of the intervention.	Day 1
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Alice PREVOST, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mandibular Reconstruction; Mandible; Computer-Aided Design; Fibular free flap; Computer Assisted three dimensional imaging; Surgical equipment
• Other Study ID Numbers: RC31/17/0347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No