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Computer Aided Evaluation of Orbital Volume

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584506
First received: December 26, 2007
Last updated: December 16, 2010
Last verified: December 2010

December 26, 2007
December 16, 2010
November 2007
July 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00584506 on ClinicalTrials.gov Archive Site
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Computer Aided Evaluation of Orbital Volume
Computer Aided Evaluation of Orbital Volume

A retrospective review to assess the performance and clinical predictive value of a novel software program (Maxillo) designed to perform complex volumetric analysis with application in the field of orbital trauma.

The concept of open reduction and internal fixation of large and complex traumatic orbital deformities is well established. It is known that successful orbital reconstruction hinges upon restoration of native orbital volume in order to establish pre-morbid function and avoid long-term complications. To date, a facile, reliable, and reproducible method to measure orbital volume has not been rendered, despite numerous approaches. The objective of this study is to assess the performance and clinical predictive value of a novel software program designed to perform complex volumetric analysis with application in the field of orbital trauma.

Observational
Time Perspective: Retrospective
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Probability Sample

Patients with complex maxillofacial and orbital trauma that underwent operative repair of orbital fractures. Computer tomography scans from a cohort of patients with normal CT data sets will also be collected to assess "normative" orbital volumes.

Orbital Fractures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chart reviews of patients at UCDMC with orbital trauma and having operative repair of the orbital fractures with post-reduction imaging included.

Exclusion Criteria:

  • Absences of post-operative imaging
Both
3 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00584506
200715801-1, IORG: 0000251
Yes
Edward B. Strong, MD, University of California Davis
University of California, Davis
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Principal Investigator: Edward B Strong, MD University of California, Davis
University of California, Davis
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP