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Advanced Visuohaptic Surgical Planning for Trauma Surgery

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01056302
First received: January 22, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Maxillofacial Injuries
 Procedure: Surgical repair of maxillofacial trauma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Advanced Visuohaptic Surgical Planning for Trauma Surgery

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Development and evaluation of the visuohaptic virtual surgery planning environment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Creation of the virtual surgical computational platform, allowing for manipulation of bony fragments on-screen


Secondary Outcome Measures:
  • Development and evaluation of automation features for the visuohaptic virtual surgery planning environment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Implementation and test of the telemedicine prototype [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: November 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
15 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center
 Procedure: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056302

Locations
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Department of Veterans Affairs
Stanford University
Investigators
Principal Investigator: Rebeka Silva, DMD VA Medical Center, San Francisco
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01056302     History of Changes
Other Study ID Numbers: F7124-R
Study First Received: January 22, 2010
Last Updated: March 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Reconstructive surgical procedures
visuohaptic

Additional relevant MeSH terms:
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013