Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Maxillofacial Injuries; Mandibular Reconstruction
• Intervention / Treatment: Other: Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Nabeul, Tunisia, 8000
    • University Hospital Mohamed Tahar Maamouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fresh cadaveric speciemen

Exclusion Criteria:

• Neck injury or previous neck dissection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Osteoperiosteal clavicular flap; Harvesting of a pedicled osteoperiosteal clavicular flap and clarification of its vascular supply

Other: Osteoperiosteal pedicled clavicular flap for mandibular and facial bone 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 ".; Other Names: Anatomical Research of the clavicular pedicled flap for mandibular reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasculature of the flap	Clavicular periosteal vessels emerging from the cervical transverse artery were highlighted and further identified after methylene blue injection	Immediately after harvesting the flap
Facial accessibility	Mandibular and zygomatic region were reached by this flap	Immediately after harvesting the flap
Bone characteristics	full-thickness bone with a length ranging between 9 and 11 centimeters.	Immediately after harvesting the flap

Collaborators and Investigators

• Sponsor: Mohamed Tahar Maamouri University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2004
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Clavicle; Mandibular reconstruction; Pedicled Flap; Bosniak Node; Microvascular Network
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Maxillofacial Injuries
• Other Study ID Numbers: Teaching Hospital Maamouri

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This research has been published.
• IPD Sharing Time Frame: Anatomical research of the clavicular pedicled flap for mandibular reconstruction: vascularization and harvesting technique
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No