Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

NCT06238076 | Recruiting

• 1 other identifier: RC31/17/0347
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Reconstruction

Keywords

Mandible; Mandibular Reconstruction; Computer-Aided Design; Fibular free flap; Computer Assisted three dimensional imaging; Surgical equipment

Outcome Measures

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.

  Day 1

Secondary Outcomes (3)

• Time of surgical procedure

  Day 1

• Qualitative assessment of the device by the surgeon

  Day 1

• Post-operative quality of life

  From 6 to 8 weeks

Study Arms (1)

Group experimental

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

Interventions

Universal surgical device FIBUMAND DEVICE

This device is made of biocompatible resin for type IIa medical devices with a 3D printer.

Group experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lateral mandibular reconstruction without symphysis reconstruction
• Legally incompetent
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31000, France

RECRUITING

Study Officials

• Alice PREVOST, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice PREVOST, MD

CONTACT

+335 61 77 95 43; prevost.a@chu-toulouse.fr

Frédéric LAUWERS, MD

CONTACT

lauwers.f@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility pilot study, monocentric, non-comparative

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 2, 2024
• Study Start: March 28, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)