Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01056302
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2010-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Advanced Visuohaptic Surgical Planning for Trauma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}], 'ancestors': [{'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rebeka.silva@va.gov', 'phone': '415-221-4810', 'title': 'Dr. Rebeka Silva', 'phoneExt': '22784', 'organization': 'Department of Veterans Affairs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': '3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center\n\nSurgical 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.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': "3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center\n\nPatients 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."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "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).", 'unitOfMeasure': 'percentage of measurement deviation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were diagnosed with acute mandibular fracture(s) and underwent surgical repair of the fracture(s) at the San Francisco VA Medical Center'}, {'type': 'SECONDARY', 'title': 'Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': "Patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center\n\nPatients 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."}], 'timeFrame': '3 years', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Implementation and Test of the Telemedicine Prototype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': "Patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center\n\nPatients 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."}], 'timeFrame': '3 years', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': '3 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center\n\nSurgical 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The study was completed with 3 datasets from patients who had maxillofacial trauma and were treated', 'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': '3 patients with maxillofacial trauma who underwent surgical repair at San Francisco VA Medical Center\n\nSurgical 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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients who underwent mandibular fracture repair had their age documented in the medical record.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of mandibular fracture', 'classes': [{'title': 'Number of total fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Number of condylar fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Number of angle fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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.', 'unitOfMeasure': 'fractures'}, {'title': 'Degree of mandibular fracture displacement', 'classes': [{'title': 'Non-displaced fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Mildly displaced fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Moderately displaced fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Severely displaced fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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.', 'unitOfMeasure': 'Fractures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2010-01-22', 'resultsFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2010-01-22', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-02', 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '6 months', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Development and Evaluation of Automation Features for the Visuohaptic Virtual Surgery Planning Environment', 'timeFrame': '3 years', 'description': '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.'}, {'measure': 'Implementation and Test of the Telemedicine Prototype', 'timeFrame': '3 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reconstructive surgical procedures', 'visuohaptic'], 'conditions': ['Maxillofacial Injuries']}, 'referencesModule': {'references': [{'pmid': '25234531', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23400144', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27898160', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Craniofacial deformity, including post-traumatic, congenital or acquired deformity\n* Patients who have already have surgery because there was a clinical indication for surgical correction\n\nExclusion Criteria:\n\n* No craniofacial deformity\n* No clinical indication for surgical correction\n* Contraindication for surgical correction'}, 'identificationModule': {'nctId': 'NCT01056302', 'briefTitle': 'Advanced Visuohaptic Surgical Planning for Trauma Surgery', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Advanced Visuohaptic Surgical Planning for Trauma Surgery', 'orgStudyIdInfo': {'id': 'F7124-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '15 patients who underwent surgical repair of mandibular fractures at San Francisco VA Medical Center', 'interventionNames': ['Procedure: Surgical repair of mandibular fractures']}], 'interventions': [{'name': 'Surgical repair of mandibular fractures', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Rebeka Silva, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}