Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-04-23 @ 9:21 PM
Study NCT ID:
NCT03057405
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009917', 'term': 'Orbital Fractures'}], 'ancestors': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of orbital volume reconstruction, as measured in Brainlab', 'timeFrame': 'immediate postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intra-operative navigation', '3D virtual planning', 'intra-operative cone beam computed tomography (CBCT)'], 'conditions': ['Orbital Fractures']}, 'descriptionModule': {'briefSummary': 'Background Correction of post traumatic and post-ablative orbita defects remains a challenge for the maxillofacial surgeon. The purpose of such intervention is the restoration of both function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention to the orbitavolume. Unfortunately, the results of such interventions today are still somewhat unpredictable.\n\nThe aim of this study is to determine whether 3D virtual planning combined with intra-operative navigation can increase the predictability of the outcome in function and aesthetics.\n\nStudy design Retrospective study. Demographic data, diagnostic and surgical parameters will be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in Brainlab software, and compared to the non-defected orbit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria\n\n* patients of all genders\n* patients of all ages\n* patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016'}, 'identificationModule': {'nctId': 'NCT03057405', 'briefTitle': 'Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction in Post-traumatic and Post-ablative Defects. Evaluation of the Potential of a Fully Integrated Brainlab Iplan System.', 'orgStudyIdInfo': {'id': 'B049201731057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intra-operative CBCT'}, {'label': '3D virtual planning + intra-operative navigation'}, {'label': '3D virtual planning + intraoperative navigation + IO CBCT'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johan Abeloos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'head of department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of department', 'investigatorFullName': 'Johan Abeloos', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}