Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nucleo de Plastica Avancada
ClinicalTrials.gov Identifier:
NCT01672619
First received: August 18, 2012
Last updated: August 22, 2012
Last verified: June 2010
  Purpose

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 Intervention
Children With Craniosynostoses
Procedure: dynamic craniotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Resource links provided by NLM:


Further study details as provided by Nucleo de Plastica Avancada:

Primary Outcome Measures:
  • Nautilus: dynamic craniotomy; new surgical technique and preliminary results [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children with craniosynostoses

Criteria

Inclusion Criteria:

  • age between 6 months to 13 years

Exclusion Criteria:

  • absence of clinical conditions for the surgical treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672619

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

Publications:
Responsible Party: Nucleo de Plastica Avancada
ClinicalTrials.gov Identifier: NCT01672619     History of Changes
Other Study ID Numbers: npa - 777 - 12
Study First Received: August 18, 2012
Last Updated: August 22, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Nucleo de Plastica Avancada:
craniosynostoses
Osteogenesis Distraction
craniotomy

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Plagiocephaly
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014