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

Craniosynostoses Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Craniosynostoses

• NCT number: NCT06366178
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Astrid POZET
• Phone: +33381218988
• Email: apozet@hcu-besancon.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Completion date: December 1, 2026