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Advanced Visuohaptic Surgical Planning for Trauma Surgery

Completed
Conditions
Maxillofacial Injuries
Registration Number
NCT01056302
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Deviation From Actual Surgical Outcome During Virtual Repair of Mandibular Fractures, Using the Novel Visuohaptic Computational Platform That Was Developed by the Investigators6 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
NameTimeMethod
Implementation and Test of the Telemedicine Prototype3 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.

Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment3 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.

Trial Locations

Locations (1)

VA Medical Center, San Francisco

🇺🇸

San Francisco, California, United States

VA Medical Center, San Francisco
🇺🇸San Francisco, California, United States

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