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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000632099
Ethics application status
Approved
Date submitted
28/07/2010
Date registered
2/08/2010
Date last updated
2/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intracranial Volume of Children With Craniosynostosis Before and After Frontoorbital Advancement
Scientific title
In patients with craniosynostosis how does intracranial volume change after frontoorbital advancement ?
Secondary ID [1] 252322 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Volume in children with Craniosynostosis and Frontoorbital Advancement 257828 0
Condition category
Condition code
Surgery 257998 257998 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Standardized Frontoorbital Advancement according to Muehling in Patients with Craniosynostosis:

Description of Surgery: Advancement of the Frontoorbital Bone Segment
Duration of Oberservational Study: 5 years
The approximate duration of the procedure varies and lies in the nature of a surgical procedure
Intervention code [1] 256887 0
Not applicable
Comparator / control treatment
N/A - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258858 0
Calculation of Intracranial Volume using segmentation technique and Magnetic Resonance Imaging before and after Standardized Frontoorbital Advancement according to Muehling
Timepoint [1] 258858 0
Timepoint 1: Prior to surgery (Standardized Frontoorbital Advancement according to Muehling)
Timepoint 2: 7 days post surgery (Standardized Frontoorbital Advancement according to Muehling)
Secondary outcome [1] 264983 0
Nil
Timepoint [1] 264983 0
Nil

Eligibility
Key inclusion criteria
- Craniosynostosis
- Frontoorbital Advancement
- Pre-operative and Post-operative Magnetic Resonance Imaging (MRI)
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- no frontoorbital advancement planned

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2789 0
Germany
State/province [1] 2789 0
Baden-Wuerttemberg

Funding & Sponsors
Funding source category [1] 257350 0
University
Name [1] 257350 0
Heidelberg University Hospital
Address [1] 257350 0
Heidelberg University Hospital
Department of Oral-Maxillofacial Surgery

Im Neuenheimer Feld 400
69120 Heidelberg

Germany
Country [1] 257350 0
Germany
Primary sponsor type
University
Name
Heidelberg University Hospital
Address
Heidelberg University Hospital
Department of Oral-Maxillofacial Surgery

Im Neuenheimer Feld 400
69120 Heidelberg

Germany
Country
Germany
Secondary sponsor category [1] 256590 0
None
Name [1] 256590 0
Address [1] 256590 0
Country [1] 256590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259372 0
Ethics Committee of Heidelberg University
Ethics committee address [1] 259372 0
Vossstrasse 9
69115 Heidelberg
Ethics committee country [1] 259372 0
Germany
Date submitted for ethics approval [1] 259372 0
Approval date [1] 259372 0
08/08/2001
Ethics approval number [1] 259372 0
240/2000

Summary
Brief summary
Craniosynostosis leads to pathological shapes of the skull. The standardized bilateral frontoorbital advancement (FOA) corrects the shape of the skull and the intracranial volume is actively increased. The extent of the intracranial volume obtained by the operation is unknown so far. The optimal extent cannot yet be predicted and has to be empirically determined by the surgeon. The purpose of this prospective examination is to determine the volume increase by 3D magnetic resonance imaging (3D-MRI) of the children operated on by means of FOA.
Using the technique of segmentation, the intracranial volume of 54 children with various forms of craniosynostosis should be measured on pre- and postoperative 3D-MRI scans. For comparisons the intracranial volume (ICV) measurements should be obtained just prior to surgery and 7 days postoperatively in the same way. The accuracy of the indirect measuring method should be validated by means of additional direct volume measurements of five dry skulls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31442 0
Address 31442 0
Country 31442 0
Phone 31442 0
Fax 31442 0
Email 31442 0
Contact person for public queries
Name 14689 0
Dr. Dr. Bibiana Kotrikova
Address 14689 0
Sophienstrasse 4
76530 Baden-Baden
Country 14689 0
Germany
Phone 14689 0
+49/(0)7221-972120
Fax 14689 0
+49/(0)7221-9721220
Email 14689 0
info@mkg-baden.de
Contact person for scientific queries
Name 5617 0
Dr. Dr. Bibiana Kotrikova
Address 5617 0
Sophienstrasse 4
76530 Baden-Baden
Country 5617 0
Germany
Phone 5617 0
+49/(0)7221-972120
Fax 5617 0
Email 5617 0
info@mkg-baden.de

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary