Advanced Visuohaptic Surgical Planning for Trauma Surgery

Maxillofacial Injuries Clinical Trial

Official title:

Advanced Visuohaptic Surgical Planning for Trauma Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056302
• Other study ID #: F7124-R
• Status: Completed
• Start date: November 2011
• Est. completion date: February 2016

Study information

• Verified date: June 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maxillofacial Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	VA Medical Center, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment	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.	3 years
Secondary	Implementation and Test of the Telemedicine Prototype	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.	3 years