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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06238076
Other study ID # RC31/17/0347
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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