Maxillofacial Injuries
Conditions
Keywords
Reconstructive surgical procedures, visuohaptic
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.
Interventions
PROCEDURESurgical 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.
Sponsors
Stanford University
VA Office of Research and Development
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 3 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center
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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Group 1 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Age, Continuous | 60 years | — |
| Degree of mandibular fracture displacement Mildly displaced fracture | 0 Fractures | — |
| Degree of mandibular fracture displacement Moderately displaced fracture | 2 Fractures | — |
| Degree of mandibular fracture displacement Non-displaced fracture | 0 Fractures | — |
| Degree of mandibular fracture displacement Severely displaced fracture | 3 Fractures | — |
| Presence of mandibular fracture Number of angle fractures | 3 fractures | — |
| Presence of mandibular fracture Number of condylar fractures | 2 fractures | — |
| Presence of mandibular fracture Number of total fractures | 5 fractures | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 3 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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).
Time frame: 6 months
Population: All participants were diagnosed with acute mandibular fracture(s) and underwent surgical repair of the fracture(s) at the San Francisco VA Medical Center
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 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 | 5 percentage of measurement deviation |
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.
Time frame: 3 years
Population: The automation feature was envisioned to predict size and position of bone plates/screws that would best fit the virtually repaired mandibular fractures. The goal was to compare the actual hardware configuration with what the software predicted. The software development proved too difficult to add this automated feature. Data were not collected.
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.
Time frame: 3 years
Population: The telemedicine prototype, which would allow an operator to quickly create a virtual surgical plan to send to a remote surgeon, predicting needed reconstructive hardware, could not be developed due to software limitations. Data were not collected.