Maxillofacial InjuriesNCT01056302
Advanced Visuohaptic Surgical Planning for Trauma Surgery
An observational study of Maxillofacial Injuries, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillofacial Injuries
- What is being tested?
- Surgical repair of mandibular fractures
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Craniofacial deformity, including post-traumatic, congenital or acquired deformity
- Patients who have already have surgery because there was a clinical indication for surgical correction
Who cannot join
- No craniofacial deformity
- No clinical indication for surgical correction
- Contraindication for surgical correction
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, San Francisco
San Francisco, California, 94121
About this study
This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.
Read the 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.
- Conditions
- Maxillofacial Injuries
- Being tested
- Surgical repair of mandibular fractures
- Keywords
- Reconstructive surgical procedures, visuohaptic
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repair of mandibular fracturesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center Receives: Procedure: Surgical repair of mandibular fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Rebeka Silva, DMD, Principal investigator, VA Medical Center, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056302
- Sponsor's protocol ID
- F7124-R
- Status last verified
- Jun 2020
- First submitted
- 22 Jan 2010
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25234531Forsslund 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.
PubMed 23400144Girod 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.
PubMed 27898160
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Visuohaptic Surgical Planning for Trauma Surgery
- ClinicalTrials.gov ID
- NCT01056302
- Acronym / sponsor ID
- F7124-R
- Conditions
- Maxillofacial Injuries
- Keywords
- Reconstructive surgical procedures, visuohaptic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Stanford University
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Surgical repair of mandibular fractures15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Craniofacial deformity, including post-traumatic, congenital or acquired deformity
- Patients who have already have surgery because there was a clinical indication for surgical correction
Key exclusion criteria (3 listed)
- No craniofacial deformity
- No clinical indication for surgical correction
- Contraindication for surgical correction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical repair of mandibular fracturesPatients 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. | Procedure or surgery | Group 1 |
Primary outcome
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
Time frame: 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).
2 secondary outcomes
Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment
Time frame: 3 years
Implementation and Test of the Telemedicine Prototype
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25234531Schvartzman 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.
- Results publication: PubMed 23400144Forsslund 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.
- Results publication: PubMed 27898160Girod 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.
- Individual participant dataSharing planned: No
Related trials for Maxillofacial Injuries
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebeka Silva, DMD principal investigator
VA Medical Center, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Injuries, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056302, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.