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
|Condition or disease||Intervention/treatment|
|Maxillofacial Injuries||Procedure: Surgical repair of mandibular fractures|
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|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|
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.
- 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).
- 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.
- 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.
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
|United States, California|
|VA Medical Center, San Francisco|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Rebeka Silva, DMD||VA Medical Center, San Francisco|