Trial Review

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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
Sex
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
1/09/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
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
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.