EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses

Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.

The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.

There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment.

A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.

The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF.

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Key information

Conditions

Craniosynostoses Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

4 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with anterior craniostenosis (organic trigonocephaly or anterior plagiocephaly), aged 4 to 24 months
Procedure performed at Besançon University Hospital
Written consent from both parents, or from one parent if there is only one, indicating that they have understood the purpose and procedures of the study, and that they agree to their child's participation in the study and to the study's requirements and restrictions.
Affiliation with a French social security scheme or beneficiary of such a scheme.
Pre-operative computed tomography scan and cone beam to measure the fronto zygomatic distance and naso-frontal angle in trigonocephaly, and to calculate the frontal process of the zygoma symmetry defect in organic anterior plagiocephaly.

Exclusion criteria

Legal incapacity or limited legal capacity of parent(s)
Subject is in the exclusion period of another study or is on the "national volunteer list".

Treatment and study plan

BONFIX system

Device

The device corresponds to a customized, single-use surgical guide (Class IIa medical device), with a set of different sizes, adapted to the fronto-zygomatic distance (FDZ) measurement, in order to enable better conformation of the orbito-naso-frontal bandeau during surgery for anterior craniostenosis, an ideal conformation that could lead to optimal symmetry and adapted to the morphology of the upper third of infants.

The surgeon conforms the orbito-naso-frontal bandeau by adapting the advancement between the device supports according to the FDZ and then positioning it directly on the surgical guide.

Primary outcomes

Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria.

Time frame: 6 months after intervention
Measurement of the frontal angle from scanned images and/or observation of symmetry or lack of symmetry of the orbito-naso-frontal bandeau :
- frontal angle
Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria.

Time frame: 6 months after intervention
Measurement of the frontal angle from scanned images and/or observation of symmetry or lack of symmetry of the orbito-naso-frontal bandeau :
- symmetry for trigonocephaly
Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria.

Time frame: 6 months after intervention
Measurement of the frontal angle from scanned images and/or observation of symmetry or lack of symmetry of the orbito-naso-frontal bandeau :
- symmetry for plagiocephaly

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid POZET

CONTACT

[email protected]

+33381218988

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses

Acronym: EPBONF

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Apr 15, 2024
Registry last updated: Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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