Overview

This trial is active, not recruiting.

Condition maxillofacial injuries
Treatment surgical repair of maxillofacial trauma
Sponsor Department of Veterans Affairs
Collaborator Stanford University
Start date November 2011
End date December 2014
Trial size 15 participants
Trial identifier NCT01056302, F7124-R

Summary

This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
15 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center
surgical repair of maxillofacial trauma
Patients will undergo whatever needed surgical repair of maxillofacial trauma that is necessary. Records such as CT imaging and plaster models of the jaws will be utilized in the standard way to plan and carry out the surgery. The CT scan will also be used within the visuohaptic computational environment to develop and evaluate the user interface. The amount of time taken to work up and plan surgery using standard surgical practice and using the computational platform will be compared. Real surgical outcome will be compared to the simulated outcome using the proposed software tool.

Primary Outcomes

Measure
Development and evaluation of the visuohaptic virtual surgery planning environment
time frame: 3 years

Secondary Outcomes

Measure
Development and evaluation of automation features for the visuohaptic virtual surgery planning environment
time frame: 3 years
Implementation and test of the telemedicine prototype
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Craniofacial deformity, including post-traumatic, congenital or acquired deformity - Patients who have already have surgery because there was a clinical indication for surgical correction Exclusion Criteria: - No craniofacial deformity - No clinical indication for surgical correction - Contraindication for surgical correction

Additional Information

Official title Advanced Visuohaptic Surgical Planning for Trauma Surgery
Principal investigator Rebeka Silva, DMD
Description The proposed tool will allow surgeons from different specialties to simulate, plan and iterate on complex procedures based on individual patient data in 3-D from a CT scan. The software will allow surgeons to both see and feel the results of their interventions - for example, the quality of the bite or bone alignment of a reconstructed jaw following severe trauma - before the actual surgery, leading to better planning, fewer errors, shortened surgery time and improved outcomes for the patients. The purpose of this study is the evaluation of a visuohaptic planning system for mandibular trauma surgery that is based on interactive manipulation of CT data.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.