Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-21 @ 12:26 PM
Study NCT ID:
NCT03023956
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-22', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of head-shaft angle at 12months from 6months in two groups', 'timeFrame': '12months'}], 'secondaryOutcomes': [{'measure': 'change of Offset at 12months from 6months in two groups', 'timeFrame': '12 months'}, {'measure': 'Constant-Murly scores at 3 months, 12 months and last follow-up', 'timeFrame': '3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )'}, {'measure': 'change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Humeral Fracture, Proximal', 'Internal Fixation; Complications, Mechanical, Bones of Limb']}, 'descriptionModule': {'briefSummary': 'From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.\n\nExclusion Criteria:\n\n* Patients had pathologic fractures,\n* Patients had previous surgery on the affected shoulder,\n* Patients were treated with shoulder arthroplasty.\n* Patients were treated with intramedullary nail.'}, 'identificationModule': {'nctId': 'NCT03023956', 'briefTitle': 'Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Zhoupu Hospital, Pudong New Area, Shanghai, China'}, 'orgStudyIdInfo': {'id': 'ZhouXuANFSNF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ANF', 'description': 'anatomic neck fractures of proximal humerus', 'interventionNames': ['Procedure: Locking plates were used for proximal humeral fractures.']}, {'label': 'SNF', 'description': 'surgical neck fractures of proximal humerus', 'interventionNames': ['Procedure: Locking plates were used for proximal humeral fractures.']}], 'interventions': [{'name': 'Locking plates were used for proximal humeral fractures.', 'type': 'PROCEDURE', 'armGroupLabels': ['ANF', 'SNF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaoxiao Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoxiao Zhou', 'investigatorAffiliation': 'Zhoupu Hospital, Pudong New Area, Shanghai, China'}}}}