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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reshaping the orbito-naso-frontal band with a guide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Measurement of the frontal angle from scanned images and/or observation of symmetry or lack of symmetry of the orbito-naso-frontal bandeau :
| 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. | 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 | 6 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid POZET | Contact | +33381218988 | apozet@hcu-besancon.fr |
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|
| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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