Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Children With Craniosynostoses Clinical Trial

— Nautilus  

Official title:

Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672619
• Other study ID #: npa - 777 - 12
• Status: Completed
• Phase: N/A
• First received: August 18, 2012
• Last updated: August 22, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2010
• Source: Nucleo de Plastica Avancada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 13 Years

Eligibility

Inclusion Criteria:

• age between 6 months to 13 years

Exclusion Criteria:

• absence of clinical conditions for the surgical treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children With Craniosynostoses
• Craniosynostoses

Intervention

Procedure:
• dynamic craniotomy
Surgical technique of craniotomy spiral without detachment of dura mater

Locations

Country	Name	City	State
Brazil	Hospital Beneficencia Portuguesa de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Nucleo de Plastica Avancada

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Lauritzen CG, 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):545-54. doi: 10.1097/01.prs.0000297638.76602.de. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes