Advanced Visuohaptic Surgical Planning for Trauma Surgery

NCT01056302 | Completed Results

• 1 other identifier: F7124-R
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillofacial Injuries

Keywords

Reconstructive surgical procedures; visuohaptic

Outcome Measures

Primary Outcomes (1)

• 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

  The virtual surgical outcome was compared to the actual surgical outcome. This was accomplished by measuring distances (mm) and angles between specific mandibular anatomic points in the virtual environment and comparing it to the same distances (mm) and angles between specific mandibular anatomic points in the actual surgical outcome, as seen in a 3D rendering derived from the patient's postoperative CT scan. The actual surgical repair was considered to be the gold standard. A deviation of more than 10% between the virtual surgical repair and the actual surgical repair was considered to be above threshold (inaccurate virtual fracture repair).

  6 months

Secondary Outcomes (2)

• Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment

  3 years

• Implementation and Test of the Telemedicine Prototype

  3 years

Study Arms (1)

Group 1

15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center

Procedure: Surgical repair of mandibular fractures

Interventions

Surgical repair of mandibular fractures PROCEDURE

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 surgical outcome using the proposed software tool.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Craniofacial deformity, including post-traumatic, congenital or acquired deformity
• Patients who have already have surgery because there was a clinical indication for surgical correction

You may not qualify if:

• No craniofacial deformity
• No clinical indication for surgical correction
• Contraindication for surgical correction

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Stanford University: collaborator

Study Sites (1)

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (3)

• 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.

  PMID: 25234531 RESULT

• 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.

  PMID: 23400144 RESULT

• 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.

  PMID: 27898160 RESULT

MeSH Terms

Conditions

Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Dr. Rebeka Silva
• Organization: Department of Veterans Affairs

rebeka.silva@va.gov

415-221-4810

Study Officials

• Rebeka Silva, DMD

  VA Medical Center, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2016
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)