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Computer Aided Evaluation of Orbital Volume

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ClinicalTrials.gov Identifier: NCT00584506
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
University of California, Davis

Brief Summary:
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.

Condition or disease
Orbital Fractures

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 250 participants
Time Perspective: Retrospective
Official Title: Computer Aided Evaluation of Orbital Volume
Study Start Date : November 2007
Primary Completion Date : July 2010
Study Completion Date : July 2010




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584506


Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Edward B Strong, MD University of California, Davis

Responsible Party: Edward B. Strong, MD, University of California Davis
ClinicalTrials.gov Identifier: NCT00584506     History of Changes
Other Study ID Numbers: 200715801-1
IORG: 0000251
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Keywords provided by University of California, Davis:
orbital fractures

Additional relevant MeSH terms:
Orbital Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries