Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Completed

• Conditions: Children With Craniosynostoses
• Interventions: Procedure: dynamic craniotomy

• Registration Number: NCT01672619
• Lead Sponsor: Nucleo de Plastica Avancada

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-08-18
• Study First Submitted QC: 2012-08-22
• Last Update Submitted: 2012-08-22
• Study First Posted: 2012-08-27
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• age between 6 months to 13 years

Exclusion Criteria

• absence of clinical conditions for the surgical treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with craniosynostosis	dynamic craniotomy	children with craniosynostosis aged 6 months to 13

Primary Outcome Measures

Name	Time	Method
Nautilus: dynamic craniotomy; new surgical technique and preliminary results	Up to 3 years	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.
cranial remodeling	Up to 3 years	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.

Trial Locations

Locations (1)

Hospital Beneficencia Portuguesa de São Paulo; 🇧🇷 São Paulo, SP, Brazil