<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672619</url>
  </required_header>
  <id_info>
    <org_study_id>npa - 777 - 12</org_study_id>
    <nct_id>NCT01672619</nct_id>
  </id_info>
  <brief_title>Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results</brief_title>
  <acronym>Nautilus</acronym>
  <official_title>Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nucleo de Plastica Avancada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nucleo de Plastica Avancada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Being the craniostenoses sutural basically a disease, the fact that the brain being trapped&#xD;
      in an enclosure that does not have complacency required to accompany their growth constitutes&#xD;
      the challenge of treatment, which aims to restore the complacency of the suture and correct&#xD;
      the stenotic compensatory cranial deformity.&#xD;
&#xD;
      This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided&#xD;
      by the use of springs distracting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling&#xD;
      of a curved surface as well as the skullcap. If you do not receive fixation, however, trace&#xD;
      the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending&#xD;
      on the direction of the force that is received. This form of osteotomy was therefore chosen&#xD;
      by the authors to induce bone compliance areas of secondary defect that should expand or&#xD;
      compress indirectly during the process of dynamic remodeling of primary defect with springs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nautilus: dynamic craniotomy; new surgical technique and preliminary results</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cranial remodeling</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Children With Craniosynostoses</condition>
  <arm_group>
    <arm_group_label>children with craniosynostosis</arm_group_label>
    <description>children with craniosynostosis aged 6 months to 13</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>dynamic craniotomy</intervention_name>
    <description>Surgical technique of craniotomy spiral without detachment of dura mater</description>
    <arm_group_label>children with craniosynostosis</arm_group_label>
    <other_name>craniotomy helicoid</other_name>
    <other_name>Craniotomy spiral</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children with craniosynostoses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 6 months to 13 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absence of clinical conditions for the surgical treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Beneficencia Portuguesa de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01321000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18300975</PMID>
  </reference>
  <verification_date>June 2010</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>craniosynostoses</keyword>
  <keyword>Osteogenesis Distraction</keyword>
  <keyword>craniotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniosynostoses</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672619
org study id: npa - 777 - 12
nct id: NCT01672619
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Nautilus: dynamic craniotomy; new surgical technique and preliminary results
time frame: Up to 3 years
description: 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.
measure: cranial remodeling
time frame: Up to 3 years
description: 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.
arm group label: children with craniosynostosis
description: children with craniosynostosis aged 6 months to 13
intervention type: Procedure
intervention name: dynamic craniotomy
description: Surgical technique of craniotomy spiral without detachment of dura mater
arm group label: children with craniosynostosis
other name: craniotomy helicoid
other name: Craniotomy spiral
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 13 Years
healthy volunteers: No
facility: 
country: Brazil
citation: 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
responsible party type: Sponsor
mesh term: Craniosynostoses