Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

NCT01672619 | Completed DMC

• 1 other identifier: npa - 777 - 12
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Children With Craniosynostoses

Keywords

craniosynostoses; Osteogenesis Distraction; craniotomy

Outcome Measures

Primary Outcomes (2)

• Nautilus: dynamic craniotomy; new surgical technique and preliminary results

  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

  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

Study Arms (1)

children with craniosynostosis

children with craniosynostosis aged 6 months to 13

Procedure: dynamic craniotomy

Interventions

dynamic craniotomy PROCEDURE

Surgical technique of craniotomy spiral without detachment of dura mater

Also known as: craniotomy helicoid, Craniotomy spiral

children with craniosynostosis

Eligibility Criteria

• Age: 6 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children with craniosynostoses

You may qualify if:

• age between 6 months to 13 years

You may not qualify if:

• absence of clinical conditions for the surgical treatment

Sponsors & Collaborators

• Nucleo de Plastica Avancada: lead

Study Sites (1)

Hospital Beneficencia Portuguesa de São Paulo

São Paulo, São Paulo, 01321000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 18300975 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2012
• First Posted: August 27, 2012
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 27, 2012

Record last verified: 2010-06

Locations

BR (1)