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NCT Number: NCT06238076

Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

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.

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Key information

Conditions

Mandibular Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, 31000, France

Location status: Recruiting

Location contact

Alice PREVOST, MD

CONTACT

[email protected]

Alice PREVOST, MD

PRINCIPAL_INVESTIGATOR

Frédéric LAUWERS, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Universal surgical device FIBUMAND

Device

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

Primary outcomes

  1. Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide.

    Time frame: 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 outcomes

  1. Time of surgical procedure

    Time frame: Day 1

    It is timed (in minutes) during the procedure and relative to the total duration of the intervention.

  2. Qualitative assessment of the device by the surgeon

    Time frame: 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 obtained

  3. Post-operative quality of life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice PREVOST, MD

CONTACT

[email protected]

+335 61 77 95 43

Frédéric LAUWERS, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: FIBUMAND

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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