Computer Modeling With Reconstruction of Maxillofacial Skeleton

This study is ongoing, but not recruiting participants.

First Received: December 22, 2007 No Changes Posted

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00583856

Purpose

Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.

Condition
Maxillofacial Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Retrospective
Official Title:	Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?

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

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.

Eligibility

Ages Eligible for Study:	11 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

UCDMC Patients with specific complex fractures

Criteria

Inclusion Criteria:

specific complex maxillofacial trauma

Exclusion Criteria:

must meet inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583856

Locations

United States, California
University of California Davis
Sacramento, California, United States, 95817

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:	University of California Davis ( Edward B. Strong, MD )
Study ID Numbers:	200614968-1
Study First Received:	December 22, 2007
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00583856 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

computer aided design
maxillofacial fracture
orbital design

Study placed in the following topic categories:

Craniocerebral Trauma
Facial Injuries
Facies
Fractures, Bone

Wounds and Injuries
Maxillofacial Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Craniocerebral Trauma
Facial Injuries
Wounds and Injuries
Maxillofacial Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009