Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-21 @ 12:31 AM
Study NCT ID:
NCT03364595
Status:
UNKNOWN
Last Update Posted:
2017-12-06
First Post:
2017-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092467', 'term': 'Radial Head and Neck Fractures'}], 'ancestors': [{'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012092', 'term': 'Replantation'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Union rate', 'timeFrame': '1 year after surgery', 'description': 'Union rate of the fracture from X-ray'}], 'secondaryOutcomes': [{'measure': 'Functional score', 'timeFrame': '1 year after surgery', 'description': 'Mayo score of injury elbow'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radial head fracture', 'replacement', 'plate'], 'conditions': ['Radial Head Fracture']}, 'descriptionModule': {'briefSummary': 'To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head', 'detailedDescription': 'From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men or women aged 18 to 65 years of age with Mason Type III radial head fracture', 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph within 1 month post injury Provision of informed consent\n\nExclusion Criteria:\n\nPathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)'}, 'identificationModule': {'nctId': 'NCT03364595', 'briefTitle': 'Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head', 'orgStudyIdInfo': {'id': 'CSGK-RGXT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plate Fixation', 'description': 'The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out', 'interventionNames': ['Procedure: plate fixation']}, {'label': 'Replacement', 'description': 'The operating surgeon will determine the positioning of the patient for surgery. During the surgery, they take out the the comminuted radial head and proceed replacement using artificial.', 'interventionNames': ['Procedure: replacement']}], 'interventions': [{'name': 'plate fixation', 'type': 'PROCEDURE', 'description': 'ORIF of the radial head fracture', 'armGroupLabels': ['Plate Fixation']}, {'name': 'replacement', 'type': 'PROCEDURE', 'description': 'replacement of the radial head fracture', 'armGroupLabels': ['Replacement']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yichong Zhang, MD', 'role': 'CONTACT', 'email': '875274428@qq.com', 'phone': '15210802766'}], 'overallOfficials': [{'name': 'Peixun Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of orthopaedics and trauma', 'investigatorFullName': 'Zhang Yichong', 'investigatorAffiliation': "Peking University People's Hospital"}}}}