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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
History of Changes
  Purpose

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
Orbital Fractures

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Computer Aided Evaluation of Orbital Volume

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Enrollment: 250
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584506

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

No publications provided

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
Study First Received: December 26, 2007
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
orbital fractures

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

ClinicalTrials.gov processed this record on May 16, 2013