Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results (Nautilus)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results|
- 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.
|Study Start Date:||June 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
children with craniosynostosis
children with craniosynostosis aged 6 months to 13
Procedure: dynamic craniotomy
Surgical technique of craniotomy spiral without detachment of dura mater
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672619
|Hospital Beneficencia Portuguesa de São Paulo|
|São Paulo, SP, Brazil, 01321000|