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

August 22, 2012 updated by: Nucleo de Plastica Avancada

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01321000
        • Hospital Beneficência Portuguesa de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children with craniosynostoses

Description

Inclusion Criteria:

  • age between 6 months to 13 years

Exclusion Criteria:

  • absence of clinical conditions for the surgical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucleo de Plastica Avancada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 18, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • npa - 777 - 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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