Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results (Nautilus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672619
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Children With Craniosynostoses Procedure: dynamic craniotomy

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 Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Group/Cohort Intervention/treatment
children with craniosynostosis
children with craniosynostosis aged 6 months to 13
Procedure: dynamic craniotomy
Surgical technique of craniotomy spiral without detachment of dura mater
Other Names:
  • craniotomy helicoid
  • Craniotomy spiral

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   6 Months to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children with craniosynostoses

Inclusion Criteria:

  • age between 6 months to 13 years

Exclusion Criteria:

  • absence of clinical conditions for the surgical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672619

Hospital Beneficencia Portuguesa de São Paulo
São Paulo, SP, Brazil, 01321000
Sponsors and Collaborators
Nucleo de Plastica Avancada

Responsible Party: Nucleo de Plastica Avancada Identifier: NCT01672619     History of Changes
Other Study ID Numbers: npa - 777 - 12
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: June 2010

Keywords provided by Nucleo de Plastica Avancada:
Osteogenesis Distraction

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities