Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Study Overview
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Brief Summary
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Being the craniostenoses sutural basically a disease, the fact that the brain being trapped in an enclosure that does not have complacency required to accompany their growth constitutes the challenge of treatment, which aims to restore the complacency of the suture and correct the stenotic compensatory cranial deformity. This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided by the use of springs distracting.

Detailed Description
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As demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling of a curved surface as well as the skullcap. If you do not receive fixation, however, trace the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending on the direction of the force that is received. This form of osteotomy was therefore chosen by the authors to induce bone compliance areas of secondary defect that should expand or compress indirectly during the process of dynamic remodeling of primary defect with springs.

Official Title
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Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Conditions
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Children With Craniosynostoses

Intervention / Treatment
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* Procedure: dynamic craniotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 6 months to 13 years Exclusion Criteria: absence of clinical conditions for the surgical treatment

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with craniosynostosis<br>children with craniosynostosis aged 6 months to 13 | Procedure: dynamic craniotomy<br>* Surgical technique of craniotomy spiral without detachment of dura mater<br>* Other names: Craniotomy spiral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nautilus: dynamic craniotomy; new surgical technique and preliminary results | This study proposes to analyze the cranial remodeling achieved through the use of a dynamic craniotomy, without detachment of the dura mater in cranial deformities caused by craniosynostosis. | Up to 3 years | 
| cranial remodeling | Quantify the results of cranial remodeling by osteotomy helicoid-shaped Nautilus by clinical and CT in 6 months after the procedure, by 3 surgeons at different times - The skull shape, postoperatively, will be assessed independently by four surgeons, who will use the following scale results: insufficient when there was no attenuation of preoperative deformity, partial, when the correction happened, but was not able to capture all the characteristics of the deformity; appropriate, when there was complete remission of cranial deformity. | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craniotomy, craniosynostoses, Osteogenesis Distraction