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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00584506
Other study ID # 200715801-1
Secondary ID IORG: 0000251
Status Completed
Phase N/A
First received December 26, 2007
Last updated December 16, 2010
Start date November 2007
Est. completion date July 2010

Study information

Verified date December 2010
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 90 Years
Eligibility 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

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis
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