Clinical trial NCT01056302: Advanced Visuohaptic Surgical Planning for Trauma Surgery
Official title: Advanced Visuohaptic Surgical Planning for Trauma Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Injuries
Keywords: Reconstructive surgical procedures
visuohaptic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Stanford University
First posted: 2010-01-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will veterans who present to the Oral/Maxillofacial Surgery Clinic at the San Francisco VA Medical Center. The study will use pre-existing data from patients undergoing reconstructive facial surgery at the San Francisco VA with clinic indications that require preoperative CT scans and preoperative radiographs as well as model casts.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Deviation From Actual Surgical Outcome During Virtual Repair of Mandibular Fractures, Using the Novel Visuohaptic Computational Platform That Was Developed by the Investigators
timeFrame: 6 months
Secondary outcomes:
measure: Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment
timeFrame: 3 years
measure: Implementation and Test of the Telemedicine Prototype
timeFrame: 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
Study officials:
affiliation: VA Medical Center, San Francisco
name: Rebeka Silva, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schvartzman SC, Silva R, Salisbury K, Gaudilliere D, Girod S. Computer-aided trauma simulation system with haptic feedback is easy and fast for oral-maxillofacial surgeons to learn and use. J Oral Maxillofac Surg. 2014 Oct;72(10):1984-93. doi: 10.1016/j.joms.2014.05.007. Epub 2014 May 24.
citation: Forsslund J, Chan S, Selesnick J, Salisbury K, Silva RG, Blevins NH. The effect of haptic degrees of freedom on task performance in virtual surgical environments. Stud Health Technol Inform. 2013;184:129-35.
citation: Girod S, Schvartzman SC, Gaudilliere D, Salisbury K, Silva R. Haptic feedback improves surgeons' user experience and fracture reduction in facial trauma simulation. J Rehabil Res Dev. 2016;53(5):561-570. doi: 10.1682/JRRD.2015.03.0043.