Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

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.

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Key information

Conditions

Children With Craniosynostoses Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

6 month–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Beneficencia Portuguesa de São Paulo

São Paulo, 01321000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age between 6 months to 13 years

Exclusion criteria

absence of clinical conditions for the surgical treatment

Treatment and study plan

dynamic craniotomy

Procedure

Surgical technique of craniotomy spiral without detachment of dura mater

Other names: craniotomy helicoid, Craniotomy spiral

Primary outcomes

Nautilus: dynamic craniotomy; new surgical technique and preliminary results

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nucleo de Plastica Avancada

Network

Registry information

Acronym: Nautilus

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 27, 2012
Registry last updated: Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed