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

Not Applicable

Not yet recruiting

• Conditions: Craniosynostoses
• Interventions: Device: BONFIX system

• Registration Number: NCT06366178
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Study Start: 2024-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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".

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
reshaping the orbito-naso-frontal band with a guide	BONFIX system	-

Primary Outcome Measures

Name	Time	Method
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.	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