Mandibular ReconstructionFIBUMANDNCT06238076
Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
A study testing Universal surgical device FIBUMAND in people with Mandibular Reconstruction, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Reconstruction
- What is being tested?
- Universal surgical device FIBUMAND
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lateral mandibular reconstruction without symphysis reconstruction
- Legally incompetent
- Inclusion in another protocol of research , involving mandibular reconstruction
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Frédéric LAUWERS, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Toulouse
Toulouse, 31000
Alice PREVOST, MD, prevost.a@chu-toulouse.fr
Frédéric LAUWERS, MD
About this study
Official title: 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.
- Conditions
- Mandibular Reconstruction
- Being tested
- Universal surgical device FIBUMAND
- Keywords
- Mandible, Mandibular Reconstruction, Computer-Aided Design, Fibular free flap, Computer Assisted three dimensional imaging, Surgical equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal surgical device FIBUMANDDevice
This device is made of biocompatible resin for type IIa medical devices with a 3D printer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Universal surgical device FIBUMAND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
Time of surgical procedure
It is timed (in minutes) during the procedure and relative to the total duration of the intervention.
Measured: 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
Measured: 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.
Measured: From 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start28 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular ReconstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study, monocentric, non-comparative
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice PREVOST, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238076
- Sponsor's protocol ID
- RC31/17/0347
- Acronym
- FIBUMAND
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
- ClinicalTrials.gov ID
- NCT06238076
- Acronym / sponsor ID
- FIBUMAND / RC31/17/0347
- Conditions
- Mandibular Reconstruction
- Keywords
- Mandible, Mandibular Reconstruction, Computer-Aided Design, Fibular free flap, Computer Assisted three dimensional imaging, Surgical equipment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study, monocentric, non-comparative
| Arm | Type | Receives |
|---|---|---|
| Group experimental | Experimental | Device: Universal surgical device FIBUMANDThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Lateral mandibular reconstruction without symphysis reconstruction
- Legally incompetent
- Inclusion in another protocol of research , involving mandibular reconstruction
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal surgical device FIBUMANDThis device is made of biocompatible resin for type IIa medical devices with a 3D printer. | Device | Group experimental |
Primary outcome
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.
3 secondary outcomes
Time of surgical procedure
Time frame: Day 1
Qualitative assessment of the device by the surgeon
Time frame: Day 1
Post-operative quality of life
Time frame: From 6 to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Mandibular Reconstruction
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
Recruiting
Mandibular Reconstruction Preplanning (ViPMR)
Oral Cavity Cancer, Oral Cancer
Not yet recruiting
Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
Alveolar Cleft Grafting
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
Active, not recruitingObservational study
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
Mandibular Fractures, Facial Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric LAUWERS, MD contact
Alice PREVOST, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal surgical device FIBUMAND in people with Mandibular Reconstruction, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice PREVOST, MD (+335 61 77 95 43, prevost.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.