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Not yet recruiting NCT06366178

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

No phase Interventional Craniosynostoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BONFIX system.
Who it may be relevant to
Registry conditions: Craniosynostoses. Basic parameters: 4 months — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device BONFIX system
    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 advancem

Primary outcome measures

  • 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]
  • 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]
  • 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]

Eligibility criteria

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".

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06366178 · 2024/864

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗