Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 1:02 PM
Study NCT ID:
NCT02850861
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2016-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative reduction time', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mandibular Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hxkq.org/', 'label': 'The West China Hospital of Stomatology has long been ranked as one of the national top hospitals in China'}]}, 'descriptionModule': {'briefSummary': 'In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.', 'detailedDescription': 'In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.\n\nExclusion Criteria:\n\n* patients refused to participate in the clinical trial;\n* condylar fracture dislocation was not obvious, conservative treatment can be used;\n* mandibular condylar comminuted fracture;\n* mandibular condyle need to be reconstructed.'}, 'identificationModule': {'nctId': 'NCT02850861', 'briefTitle': 'A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor', 'orgStudyIdInfo': {'id': 'WCH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures.', 'interventionNames': ['Device: Condylar reductor']}, {'type': 'NO_INTERVENTION', 'label': 'The control group', 'description': 'In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures.'}], 'interventions': [{'name': 'Condylar reductor', 'type': 'DEVICE', 'description': 'A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.', 'armGroupLabels': ['The experimental group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lei Liu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'West China Hospital of Stomotalogy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Junhui Cui', 'class': 'OTHER'}, 'collaborators': [{'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Junhui Cui', 'investigatorAffiliation': 'West China Hospital'}}}}