Trial Outcomes & Findings for Advanced Visuohaptic Surgical Planning for Trauma Surgery (NCT NCT01056302)
NCT ID: NCT01056302
Last Updated: 2020-07-07
Results Overview
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).
COMPLETED
3 participants
6 months
2020-07-07
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
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0
|
|
Overall Study
STARTED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=3 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
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Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
60 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
|
Region of Enrollment
United States
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3 participants
n=3 Participants
|
|
Presence of mandibular fracture
Number of total fractures
|
5 fractures
n=3 Participants
|
|
Presence of mandibular fracture
Number of condylar fractures
|
2 fractures
n=3 Participants
|
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Presence of mandibular fracture
Number of angle fractures
|
3 fractures
n=3 Participants
|
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Degree of mandibular fracture displacement
Non-displaced fracture
|
0 Fractures
n=3 Participants
|
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Degree of mandibular fracture displacement
Mildly displaced fracture
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0 Fractures
n=3 Participants
|
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Degree of mandibular fracture displacement
Moderately displaced fracture
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2 Fractures
n=3 Participants
|
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Degree of mandibular fracture displacement
Severely displaced fracture
|
3 Fractures
n=3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants were diagnosed with acute mandibular fracture(s) and underwent surgical repair of the fracture(s) at the San Francisco VA Medical Center
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).
Outcome measures
| Measure |
Group 1
n=3 Participants
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.
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|---|---|
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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
Interval 1.0 to 7.0
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SECONDARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place