Mandibular ReconstructionNCT06255483
Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction
A study testing Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction in people with Mandibular Reconstruction and Maxillofacial Injuries, run by Mohamed Tahar Maamouri University Hospital at 1 site in Tunisia.
Trial summary
Because of the proximity of the clavicular bone to the oral cavity, and the suitable characteristics of the bone for implant placement, its use as a pedicled flap is an attractive method of mandibular reconstruction. Read more about this study
- Who is it for?
- Ages 42 to 65 years
- Conditions the study is for
- Mandibular Reconstruction, Maxillofacial Injuries
- What is being tested?
- Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2004to 24 Jan 2023
- 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 42 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fresh cadaveric speciemen
Who cannot join
- Neck injury or previous neck dissection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction: Vascularization and Harvesting Technique
Because of the proximity of the clavicular bone to the oral cavity, and the suitable characteristics of the bone for implant placement, its use as a pedicled flap is an attractive method of mandibular reconstruction. This research, performed on fresh cadaver specimens, describes the vascular supply and harvesting technique of a pedicled clavicular bone allowing a mandibular reconstruction with a single surgical field.
Read the detailed description
An osteoperiosteal clavicular flap was harvested from the right side, on 10 fresh male cadaver specimens whose age of death ranged between 42 and 65 years. The dissection was carried out by the investigator at the laboratory of the Anatomy of René Descartes University of Medicine in Paris in 2004, as well as in the Forensic Medicine Department of Mohamed Tahar Maamouri University Hospital in Tunisia.
Technical steps for harvesting the pedicled osteoperiosteal clavicular flap:
The cadaver is placed in dorsal recumbency, and a pad under the shoulders. A cervical incision with a " Z " shape was performed in which the upper branch was placed two centimeters below and parallel to the inferior jawline to preserve the marginal mandibular nerve. The vertical branch of the incision continued following the path of the sternocleidomastoid muscle and reached the lower branch of the " Z " at the level of the clavicle.
The dissection was carried out in the cervical region's sub-platysmal plane and the pre-pectoral and pre-deltoid planes. The deep plane can be approached through an incision of the superficial cervical fascia overlying the sternocleidomastoid muscle taking into consideration the spinal accessory nerve. Then, the clavicle was released from the sternocleidomastoid muscle, but the subclavius muscle insertion was preserved on the clavicle to protect the subclavian vein branches. The level of undermining dissection was confined to the loose fat pad overlaying the scalene muscle, within which the vessels are embedded without exposing the brachial plexus.
The anterior surface of the subclavian vein was exposed, and the vessels arising from this vein were ligated. The clavicular bone attached to a celluloadipous pedicle has been lifted exposing the thyrocervical trunk. A celluloadipous tissue around the branches of this trunk (cervical transverse artery, inferior thyroid artery, ascending cervical artery, and suprascapular artery) was preserved in their dissection, and care was taken to avoid injury of the phrenic nerve, noticeable near the inferior thyroid artery. Then, the cervical transverse and suprascapular arteries were ligated at their distal part. Nevertheless, the inferior thyroid artery could be also ligated, which increases the total pedicle length of the flap and improves its arc of rotation. Otherwise, the flap will be bi-pedicled. The ascending cervical artery was dissected along the anterior scalene muscle up to the level of the transverse process of the fourth cervical vertebrae which is considered the vascular pedicle rotation point.
The vascular supply of the clavicular flap was highlighted by injecting the thyrocervical trunk with coloured latex after ligating the following arteries at their distal parts: the inferior thyroid, the suprascapular, and the cervical transverse.
- Conditions
- Mandibular Reconstruction, Maxillofacial Injuries
- Being tested
- Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction
- Keywords
- Clavicle, Pedicled Flap, Bosniak Node, Microvascular Network, Mandibular reconstruction
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstructionOther
Also called Anatomical Research of the clavicular pedicled flap for mandibular reconstruction
A clavicular flap with a vascular supply based on the transverse cervical artery which receives a reverse blood supply from the ascending cervical artery. This vascular pattern is reliable because of the existence of the sub-occipital microvascular network named the " Bosniak node ".
| Study group | Role | What they receive |
|---|---|---|
| Osteoperiosteal clavicular flap | Other | Harvesting of a pedicled osteoperiosteal clavicular flap and clarification of its vascular supply Receives: Other: Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasculature of the flap
Clavicular periosteal vessels emerging from the cervical transverse artery were highlighted and further identified after methylene blue injection
Measured: Immediately after harvesting the flap
Facial accessibility
Mandibular and zygomatic region were reached by this flap
Measured: Immediately after harvesting the flap
Bone characteristics
full-thickness bone with a length ranging between 9 and 11 centimeters.
Measured: Immediately after harvesting the flap
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2004
- Primary completion7 Oct 2022
- Study completion24 Jan 2023
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.
- 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
- Model description
- The harvest of a pedicle osteoperiosteal clavicular flap was performed in the same way on ten fresh cadaveric specimens. The vascular supply was studied by colored latex and methylene blue injections.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Tahar Maamouri University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Turki Mehri, MD, Mohamed Tahar Maamouri University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255483
- Sponsor's protocol ID
- Teaching Hospital Maamouri
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This research has been published.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction: Vascularization and Harvesting Technique
- ClinicalTrials.gov ID
- NCT06255483
- Acronym / sponsor ID
- Teaching Hospital Maamouri
- Conditions
- Mandibular Reconstruction, Maxillofacial Injuries
- Keywords
- Clavicle, Pedicled Flap, Bosniak Node, Microvascular Network, Mandibular reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mohamed Tahar Maamouri University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 13 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.
Because of the proximity of the clavicular bone to the oral cavity, and the suitable characteristics of the bone for implant placement, its use as a pedicled flap is an attractive method of mandibular reconstruction. This research, performed on fresh cadaver specimens, describes the vascular supply and harvesting technique of a pedicled clavicular bone allowing a mandibular reconstruction with a single surgical field.
Detailed description
An osteoperiosteal clavicular flap was harvested from the right side, on 10 fresh male cadaver specimens whose age of death ranged between 42 and 65 years. The dissection was carried out by the investigator at the laboratory of the Anatomy of René Descartes University of Medicine in Paris in 2004, as well as in the Forensic Medicine Department of Mohamed Tahar Maamouri University Hospital in Tunisia.
Technical steps for harvesting the pedicled osteoperiosteal clavicular flap:
The cadaver is placed in dorsal recumbency, and a pad under the shoulders. A cervical incision with a " Z " shape was performed in which the upper branch was placed two centimeters below and parallel to the inferior jawline to preserve the marginal mandibular nerve. The vertical branch of the incision continued following the path of the sternocleidomastoid muscle and reached the lower branch of the " Z " at the level of the clavicle.
The dissection was carried out in the cervical region's sub-platysmal plane and the pre-pectoral and pre-deltoid planes. The deep plane can be approached through an incision of the superficial cervical fascia overlying the sternocleidomastoid muscle taking into consideration the spinal accessory nerve. Then, the clavicle was released from the sternocleidomastoid muscle, but the subclavius muscle insertion was preserved on the clavicle to protect the subclavian vein branches. The level of undermining dissection was confined to the loose fat pad overlaying the scalene muscle, within which the vessels are embedded without exposing the brachial plexus.
The anterior surface of the subclavian vein was exposed, and the vessels arising from this vein were ligated. The clavicular bone attached to a celluloadipous pedicle has been lifted exposing the thyrocervical trunk. A celluloadipous tissue around the branches of this trunk (cervical transverse artery, inferior thyroid artery, ascending cervical artery, and suprascapular artery) was preserved in their dissection, and care was taken to avoid injury of the phrenic nerve, noticeable near the inferior thyroid artery. Then, the cervical transverse and suprascapular arteries were ligated at their distal part. Nevertheless, the inferior thyroid artery could be also ligated, which increases the total pedicle length of the flap and improves its arc of rotation. Otherwise, the flap will be bi-pedicled. The ascending cervical artery was dissected along the anterior scalene muscle up to the level of the transverse process of the fourth cervical vertebrae which is considered the vascular pedicle rotation point.
The vascular supply of the clavicular flap was highlighted by injecting the thyrocervical trunk with coloured latex after ligating the following arteries at their distal parts: the inferior thyroid, the suprascapular, and the cervical transverse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The harvest of a pedicle osteoperiosteal clavicular flap was performed in the same way on ten fresh cadaveric specimens. The vascular supply was studied by colored latex and methylene blue injections.
| Arm | Type | Receives |
|---|---|---|
| Osteoperiosteal clavicular flap | Other | Other: Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstructionHarvesting of a pedicled osteoperiosteal clavicular flap and clarification of its vascular supply |
Who may qualify
- Ages
- 42 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fresh cadaveric speciemen
Key exclusion criteria (1 listed)
- Neck injury or previous neck dissection
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 |
|---|---|---|
| Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstructionAlso: Anatomical Research of the clavicular pedicled flap for mandibular reconstructionA clavicular flap with a vascular supply based on the transverse cervical artery which receives a reverse blood supply from the ascending cervical artery. This vascular pattern is reliable because of the existence of the sub-occipital microvascular network named the " Bosniak node ". | Other | Osteoperiosteal clavicular flap |
Primary outcome
Vasculature of the flap
Time frame: Immediately after harvesting the flap
Clavicular periosteal vessels emerging from the cervical transverse artery were highlighted and further identified after methylene blue injection
Facial accessibility
Time frame: Immediately after harvesting the flap
Mandibular and zygomatic region were reached by this flap
Bone characteristics
Time frame: Immediately after harvesting the flap
full-thickness bone with a length ranging between 9 and 11 centimeters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Yes. This research has been published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction in people with Mandibular Reconstruction and Maxillofacial Injuries, run by Mohamed Tahar Maamouri University Hospital at 1 site in Tunisia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vasculature of the flap (time frame: Immediately after harvesting the flap). The study lists 3 primary outcomes in all. 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 13 Feb 2024.