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Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

NCT ID: NCT01672619

Last Updated: 2012-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Children With Craniosynostoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children with craniosynostosis

children with craniosynostosis aged 6 months to 13

dynamic craniotomy

Intervention Type PROCEDURE

Surgical technique of craniotomy spiral without detachment of dura mater

Interventions

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dynamic craniotomy

Surgical technique of craniotomy spiral without detachment of dura mater

Intervention Type PROCEDURE

Other Intervention Names

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craniotomy helicoid Craniotomy spiral

Eligibility Criteria

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Inclusion Criteria

* age between 6 months to 13 years

Exclusion Criteria

* absence of clinical conditions for the surgical treatment
Minimum Eligible Age

6 Months

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nucleo de Plastica Avancada

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Beneficencia Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Lauritzen CGK, Davis C, Ivarsson A, Sanger C, Hewitt TD. The evolving role of springs in craniofacial surgery: the first 100 clinical cases. Plast Reconstr Surg. 2008 Feb;121(2):545-554. doi: 10.1097/01.prs.0000297638.76602.de.

Reference Type BACKGROUND
PMID: 18300975 (View on PubMed)

Other Identifiers

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npa - 777 - 12

Identifier Type: -

Identifier Source: org_study_id

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