Mandibular Reconstruction Using Free Fibula Flap Clinical Trial
Official title:
Mandibular Vertical Height Augmentation in Segmental Defects Using Combined Vascularized and Non-Vascularized Fibula Flap
| Verified date | January 2020 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 7 |
| Est. completion date | February 1, 2021 |
| Est. primary completion date | February 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Patient who require mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis. - Patient with Mandibular defect >9 cm. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Height of mandible | Amount of vertical height gain (Mandibular augmentation) using Multi-slice CT Scan - Measured in millimeters | one year | |
| Secondary | Patient Satisfaction: Visual analogue Scale | Patient Satisfaction using Visual analogue Scale - Scale from 0-10 | One year |