Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results (Nautilus)
|ClinicalTrials.gov Identifier: NCT01672619|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : August 27, 2012
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 or disease||Intervention/treatment|
|Children With Craniosynostoses||Procedure: dynamic craniotomy|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
children with craniosynostosis
children with craniosynostosis aged 6 months to 13
Procedure: dynamic craniotomy
Surgical technique of craniotomy spiral without detachment of dura mater
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672619
|Hospital Beneficencia Portuguesa de São Paulo|
|São Paulo, SP, Brazil, 01321000|