Mandibular Reconstruction Using Free Fibula FlapNCT04219683
Mandibular Vertical Height Augmentation in Segmental Defects Using Combined Vascularized and Non-Vascularized Fibula Flap
A study testing Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap in people with Mandibular Reconstruction Using Free Fibula Flap, run by Cairo University.
Trial summary
Segmental mandibulectomy, often employed for resection of a tumour, and occasionally for trauma, osteoradionecrosis, or osteomyelitis, adversely affects patient's quality of life (QoL) to a varying degree. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Reconstruction Using Free Fibula Flap
- What is being tested?
- Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient who require mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
Who cannot join
- Patients with systemic condition counteracting with the surgical procedure.
- Patients with conditions contraindicating fibular flap.
- Patients with extensive defects of the mandible where the length of the harvested fibula flap would not allow for simultaneous ipsilateral harvesting of a non-vascularized segment.
About this study
Segmental mandibulectomy, often employed for resection of a tumour, and occasionally for trauma, osteoradionecrosis, or osteomyelitis, adversely affects patient's quality of life (QoL) to a varying degree. It inflicts a significant defect in the head and neck region, impacting on facial appearance, and the functions of speech, malocclusion, mastication, swallowing, and health-related QoL. Mandible resection thus creates a significant impact on a patient's life, both aesthetically as well as functionally.
Restoration of the defects following resection of any part of the mandible presents a challenging problem for reconstructive surgeons. Since the introduction of fibula free flap (FFF) by Taylor in 1975, it has become the most popular choice for mandible reconstruction. Hidalgo popularized the FFF, and reported on its versatility with satisfactory outcomes. The utility and techniques of free flap mandible reconstruction have advanced in the past 2 decades, with success rate up from 82.6% to 100%. As the longest bone segment available for reconstructive purpose, FFF is known for its wide variety of applications, following mandible resection, including angle-to-angle reconstruction.
Read more
The fibula-free flap is currently considered the most popular, 'the gold standard and the workhorse flap' for mandibular reconstruction.
However, because of the limited diameter of the fibula flap compared with the height of the mandible, vertical distance between the reconstructed segment and the occlusal plane can be substantial. This is a particular problem in the dentate mandible, especially when rehabilitation with dental implants or an implant-borne denture is contemplated. Insufficient bone height leads to overloading of osteointegrated implants and endangers the longevity of the prosthetic restoration. Insufficient bone height and poor soft tissue overlying the bone flap also create an unfavourable environment for the tissue-borne prosthesis.
Such issues are particularly acute in patients with intact alveolar bone and dentition at healthy sites. The double-barrel technique, distraction osteogenesis, non-vascularized bone grafts, and guided-bone regeneration have all been used to resolve this. The double-barrel technique is a good method, but drawbacks include excess height of the neomandible and the considerable time required to contour and adapt the upper barrel. Distraction osteogenesis is a valuable and predictable treatment option; however, its wide application is limited by complexity of the surgery and the need for additional secondary surgery.
To Overcome these challenges the investigators design a technique for mandibular reconstruction where free vascularized fibula flap is splitted and non-vascularized fibula graft is harvest from same leg and is placed between two splitted parts of free fibula flap to increase vertical height of fibula.
- Being tested
- Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap
- Keywords
- free fibula flap - Mandibular reconstruction - Segmental Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flapProcedure or surgery
Using Free Fibula Flap for reconstruction of mandibular segemental defect
| Study group | Role | What they receive |
|---|---|---|
| Patient with resected Mandible | Experimental | Patient with resected mandible who is candidate for free fibula flap Receives: Procedure: Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of mandible
Amount of vertical height gain (Mandibular augmentation) using Multi-slice CT Scan - Measured in millimeters
Measured: one year
Secondary outcomes (1)
Patient Satisfaction: Visual analogue Scale
Patient Satisfaction using Visual analogue Scale - Scale from 0-10
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Reconstruction Using Free Fibula FlapStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Magdy AbdelMoaz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219683
- Sponsor's protocol ID
- CEBD-CU-2020-01-03
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Vertical Height Augmentation in Segmental Defects Using Combined Vascularized and Non-Vascularized Fibula Flap
- ClinicalTrials.gov ID
- NCT04219683
- Acronym / sponsor ID
- CEBD-CU-2020-01-03
- Keywords
- free fibula flap - Mandibular reconstruction - Segmental Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 7 Jan 2020 (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.
Segmental mandibulectomy, often employed for resection of a tumour, and occasionally for trauma, osteoradionecrosis, or osteomyelitis, adversely affects patient's quality of life (QoL) to a varying degree. It inflicts a significant defect in the head and neck region, impacting on facial appearance, and the functions of speech, malocclusion, mastication, swallowing, and health-related QoL. Mandible resection thus creates a significant impact on a patient's life, both aesthetically as well as functionally.
Restoration of the defects following resection of any part of the mandible presents a challenging problem for reconstructive surgeons. Since the introduction of fibula free flap (FFF) by Taylor in 1975, it has become the most popular choice for mandible reconstruction. Hidalgo popularized the FFF, and reported on its versatility with satisfactory outcomes. The utility and techniques of free flap mandible reconstruction have advanced in the past 2 decades, with success rate up from 82.6% to 100%. As the longest bone segment available for reconstructive purpose, FFF is known for its wide variety of applications, following mandible resection, including angle-to-angle reconstruction.
The fibula-free flap is currently considered the most popular, 'the gold standard and the workhorse flap' for mandibular reconstruction.
However, because of the limited diameter of the fibula flap compared with the height of the mandible, vertical distance between the reconstructed segment and the occlusal plane can be substantial. This is a particular problem in the dentate mandible, especially when rehabilitation with dental implants or an implant-borne denture is contemplated. Insufficient bone height leads to overloading of osteointegrated implants and endangers the longevity of the prosthetic restoration. Insufficient bone height and poor soft tissue overlying the bone flap also create an unfavourable environment for the tissue-borne prosthesis.
Such issues are particularly acute in patients with intact alveolar bone and dentition at healthy sites. The double-barrel technique, distraction osteogenesis, non-vascularized bone grafts, and guided-bone regeneration have all been used to resolve this. The double-barrel technique is a good method, but drawbacks include excess height of the neomandible and the considerable time required to contour and adapt the upper barrel. Distraction osteogenesis is a valuable and predictable treatment option; however, its wide application is limited by complexity of the surgery and the need for additional secondary surgery.
To Overcome these challenges the investigators design a technique for mandibular reconstruction where free vascularized fibula flap is splitted and non-vascularized fibula graft is harvest from same leg and is placed between two splitted parts of free fibula flap to increase vertical height of fibula.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with resected Mandible | Experimental | Procedure: Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flapPatient with resected mandible who is candidate for free fibula flap |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient who require mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
Key exclusion criteria (3 listed)
- Patients with systemic condition counteracting with the surgical procedure.
- Patients with conditions contraindicating fibular flap.
- Patients with extensive defects of the mandible where the length of the harvested fibula flap would not allow for simultaneous ipsilateral harvesting of a non-vascularized segment.
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 |
|---|---|---|
| Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flapUsing Free Fibula Flap for reconstruction of mandibular segemental defect | Procedure or surgery | Patient with resected Mandible |
Primary outcome
Height of mandible
Time frame: one year
Amount of vertical height gain (Mandibular augmentation) using Multi-slice CT Scan - Measured in millimeters
1 secondary outcome
Patient Satisfaction: Visual analogue Scale
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap in people with Mandibular Reconstruction Using Free Fibula Flap, run by Cairo University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height of mandible (time frame: one year). 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 7 Jan 2020.