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Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01672619
Acronym
Nautilus
Enrollment
10
Registered
2012-08-27
Start date
2010-06-30
Completion date
2012-06-30
Last updated
2012-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children With Craniosynostoses

Keywords

craniosynostoses, Osteogenesis Distraction, craniotomy

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.

Interventions

Surgical technique of craniotomy spiral without detachment of dura mater

Sponsors

Nucleo de Plastica Avancada
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 13 Years
Healthy volunteers
No

Inclusion criteria

* age between 6 months to 13 years

Exclusion criteria

* absence of clinical conditions for the surgical treatment

Design outcomes

Primary

MeasureTime frameDescription
Nautilus: dynamic craniotomy; new surgical technique and preliminary resultsUp to 3 yearsThis 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 remodelingUp to 3 yearsQuantify 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026