Children With CraniosynostosesNautilusNCT01672619
Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
An observational study of Children With Craniosynostoses, run by Nucleo de Plastica Avancada at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 6 months to 13 years
- Conditions the study is for
- Children With Craniosynostoses
- What is being tested?
- dynamic craniotomy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: children with craniosynostoses
Who may be able to join
- age between 6 months to 13 years
Who cannot join
- absence of clinical conditions for the surgical treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Beneficencia Portuguesa de São Paulo
São Paulo, São Paulo, 01321000
About this study
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.
Read the detailed 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.
- Conditions
- Children With Craniosynostoses
- Being tested
- dynamic craniotomy
- Keywords
- craniosynostoses, Osteogenesis Distraction, craniotomy
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic craniotomyProcedure or surgery
Also called craniotomy helicoid, Craniotomy spiral
Surgical technique of craniotomy spiral without detachment of dura mater
| Study group | Role | What they receive |
|---|---|---|
| children with craniosynostosis | children with craniosynostosis aged 6 months to 13 Receives: Procedure: dynamic craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children With CraniosynostosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleo de Plastica Avancada
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672619
- Sponsor's protocol ID
- npa - 777 - 12
- Acronym
- Nautilus
- Status last verified
- Jun 2010
- First submitted
- 18 Aug 2012
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18300975
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
- ClinicalTrials.gov ID
- NCT01672619
- Acronym / sponsor ID
- Nautilus / npa - 777 - 12
- Conditions
- Children With Craniosynostoses
- Keywords
- craniosynostoses, Osteogenesis Distraction, craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nucleo de Plastica AvancadaResearch network
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with craniosynostosis | – | Procedure: dynamic craniotomychildren with craniosynostosis aged 6 months to 13 |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with craniosynostoses
Key inclusion criteria (1 listed)
- age between 6 months to 13 years
Key exclusion criteria (1 listed)
- absence of clinical conditions for the surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic craniotomyAlso: craniotomy helicoid, Craniotomy spiralSurgical technique of craniotomy spiral without detachment of dura mater | Procedure or surgery | children with craniosynostosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Background: PubMed 18300975Lauritzen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Craniosynostoses, run by Nucleo de Plastica Avancada at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nautilus: dynamic craniotomy; new surgical technique and preliminary results (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.