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Advanced Visuohaptic Surgical Planning for Trauma Surgery

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ClinicalTrials.gov Identifier: NCT01056302
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment
Maxillofacial Injuries Procedure: Surgical repair of mandibular fractures

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.

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Advanced Visuohaptic Surgical Planning for Trauma Surgery
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center
Procedure: Surgical repair of mandibular fractures
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.




Primary Outcome Measures :
  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 [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment [ Time Frame: 3 years ]
    The addition of automation features for the visuohaptic virtual surgical planning environment was envisioned to make it possible to predict the number, type, size, and position of reconstruction hardware (bone plates and screws) that would best fit the virtually repaired mandibular fractures. The goal was to compare the hardware configuration selected and used in the actual surgical repair for the 3 participating patients with what the software predicted. Unfortunately, the software development proved to be difficult to add this automated feature.

  2. Implementation and Test of the Telemedicine Prototype [ Time Frame: 3 years ]
    Measurement of the accuracy of the virtual surgical repair generated by the surgeon operating the software when a remote surgeon digitally sends a CT scan of a patient with an acute mandibular fracture(s). The telemedicine interface would require an automated method to segment the CT scan into the fractured components. The operator would manipulate the bone fractures, select the hardware type and size for "best fit", and generate a report back to the remote surgeon.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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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
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Principal Investigator: Rebeka Silva, DMD VA Medical Center, San Francisco
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01056302    
Other Study ID Numbers: F7124-R
First Posted: January 26, 2010    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
Reconstructive surgical procedures
visuohaptic
Additional relevant MeSH terms:
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Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries