Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanford University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair of mandibular fractures | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebeka Silva, DMD | VA Medical Center, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, San Francisco | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25234531 | Result | 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.joms.2014.05.007. Epub 2014 May 24. | |
| 23400144 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Patients who underwent mandibular fracture repair had their age documented in the medical record. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All participants were diagnosed with acute mandibular fracture(s) and underwent surgical repair of the fracture(s) at the San Francisco VA Medical Center | Posted | Mean | 95% Confidence Interval | percentage of measurement deviation | 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | 3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center Surgical repair of mandibular fracture(s): Patients will undergo whatever needed surgical repair of mandibular fracture(s) that is necessary. Records such as CT imaging were utilized in the standard way to plan and carry out the surgery. The CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebeka Silva | Department of Veterans Affairs | 415-221-4810 | 22784 | rebeka.silva@va.gov |
Not provided
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| ID | Term |
|---|---|
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 years |
| 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 |
| 27898160 | Result | 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. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Presence of mandibular fracture | The number of mandibular fractures for all participating patients was recorded. Each patient underwent a preoperative workup, including CT scan, to count the number of fractures present within the mandible. | Number | fractures |
|
| Degree of mandibular fracture displacement | The mandibular fractures for all participating patients were described in terms of degree of displacement using standard medical terminology (nondisplaced, mild-, moderate- or severely displaced). Each patient underwent a preoperative workup, including clinical examination and CT scan, in order to assess the degree of fracture displacement. | Number | Fractures |
|
| OG000 | Group 1 | 3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center Patients underwent surgical repair of their mandibular fracture(s) in the usual and customary way. Preoperative CT imaging was utilized by the surgeon to plan and carry out the surgery. Following surgery, a postoperative CT scan was done to assess the success of the surgery to accurately reposition all the fractured bone. Each patient's preoperative CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface. Once the software was deemed suitable for use, it was tested. The test consisted of measuring the accuracy of the virtual surgical repair compared to the real surgical outcome, as seen on the postoperative CT scan. |
|
|
| 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. | 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. | Posted | 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. | 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. | Posted | 3 years |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided
Not provided
| D014947 |
| Wounds and Injuries |