We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advanced Visuohaptic Surgical Planning for Trauma Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by VA Office of Research and Development.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056302
First Posted: January 26, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanford University
Information provided by (Responsible Party):
VA Office of Research and Development
  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:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Development and evaluation of the visuohaptic virtual surgery planning environment [ Time Frame: 3 years ]
    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 ]
  • Implementation and test of the telemedicine prototype [ Time Frame: 3 years ]

Estimated Enrollment: 15
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056302


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

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01056302     History of Changes
Other Study ID Numbers: F7124-R
F7124-R ( Other Grant/Funding Number: VA Rehabilitation Research & Development )
First Submitted: January 22, 2010
First Posted: January 26, 2010
Last Update Posted: October 12, 2017
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
Reconstructive surgical procedures
visuohaptic

Additional relevant MeSH terms:
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries