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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-24
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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".

Trial design

Treatments tested in this trial

  • BONFIX system

Treatment groups

5 Participants
are divided into 1 treatment group

Locations

This trial has no locations