Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01487018
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015051', 'term': 'Zygomatic Fractures'}, {'id': 'D005146', 'term': 'Facial Asymmetry'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Zygomatic Symmetry', 'timeFrame': '1 month', 'description': 'Measurement the zygomatic symmetry of postoperative CT scan'}], 'secondaryOutcomes': [{'measure': 'Accuracy evaluation of CT image', 'timeFrame': '1 month', 'description': 'Anatomic contour of pre-operation design affected side was superimposed on postoperative one. Discrepancy between preoperative simulation and postoperative result was calculated.'}, {'measure': 'Facial Symmetry', 'timeFrame': '3 month', 'description': 'Facial symmetry on the Visual Analog Scale and three-dimensional camera'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Zygomatic Fractures', 'Surgery, Computer-Assisted', 'Facial Asymmetry'], 'conditions': ['Zygomatic Fractures']}, 'descriptionModule': {'briefSummary': 'Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. However, the development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.', 'detailedDescription': 'Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. Even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.However,The development of Computer-Assisted Navigation technology Offers new opportunities in the treatment of such deformities. With the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. In this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. post-traumatic unilateral deformities of the zygomaticomaxillary complex\n2. The interval after the primary injury should be more than 21 days\n3. Meet the operation indication\n4. Voluntarily join this study with informed consents\n\nExclusion Criteria:\n\n1. Obviously asymmetric of craniofacial structure\n2. Poor compliance of patient\n3. Any other condition that do not fit to participate in the study'}, 'identificationModule': {'nctId': 'NCT01487018', 'briefTitle': 'Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Evaluation of the Application of Point-to-Point Computer-Assisted Navigation for Mirroring-Reconstructing of Unilateral Posttraumatic Zygomatic Deformity: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'gongx31480528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation Surgery', 'description': 'To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.', 'interventionNames': ['Procedure: Navigation Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Surgery', 'description': 'To compare with the experimental arm.', 'interventionNames': ['Procedure: Traditional Surgery']}], 'interventions': [{'name': 'Navigation Surgery', 'type': 'PROCEDURE', 'otherNames': ['Computer-Aided Surgery', 'Surgical Navigation'], 'description': 'To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.', 'armGroupLabels': ['Navigation Surgery']}, {'name': 'Traditional Surgery', 'type': 'PROCEDURE', 'otherNames': ['Control Group'], 'description': 'To compare with the experamental group.', 'armGroupLabels': ['Traditional Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100081', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yi Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology', 'investigatorFullName': 'Gong Xi', 'investigatorAffiliation': 'Peking University'}}}}