Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-27 @ 11:15 AM
Study NCT ID:
NCT04776551
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2021-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Fixation of Acute Scaphoid Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-31', 'releaseDate': '2022-06-22'}], 'estimatedResultsFirstSubmitDate': '2022-06-22'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2021-02-14', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of wrist power', 'timeFrame': 'Up to 18 months', 'description': 'Modified Mayo wrist score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scaphoid Fracture']}, 'descriptionModule': {'briefSummary': 'Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw', 'detailedDescription': 'Aim of the work:\n\nTo assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.\n\nOperative Technique:\n\nAnesthesia: carried out under general anesthesia or brachial plexus block and under tourniquet control.\n\nPosition: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture. Recording any intraoperative complication that may affect the result.\n\nPostoperative Follow Up:\n\nShort arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Acute stable non displaced waist fracture (A2).\n* Acute unstable oblique distal third (B1).\n* Acute unstable displaced waist (B2).\n* Acute un stable fracture dislocation (B4).\n* Acute un stable comminuted fracture (B5).\n\nExclusion Criteria:\n\n* \\- Acute stable fracture tubercle (A1).\n* Acute unstable fracture proximal pole (B3).\n* Delayed union fracture (C).\n* Established non-union fracture includes fibrous (D1) and sclerotic (D2).\n* Bilateral fractures because of possible interference with postoperative grip strength measurement.'}, 'identificationModule': {'nctId': 'NCT04776551', 'briefTitle': 'Percutaneous Fixation of Acute Scaphoid Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Percutaneous Trans-trapezial Fixation of Acute Scaphoid Fractures by Herbert Screw', 'orgStudyIdInfo': {'id': 'Soh-Med-21-2-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group (1)', 'description': 'group (1) who are complaining of acute scaphoid fractures,we will do percutaneous trans trapezial fixation of scaphoid by Herbert screw.Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.', 'interventionNames': ['Procedure: Percutaneous fixation of acute Scaphoid fractures']}], 'interventions': [{'name': 'Percutaneous fixation of acute Scaphoid fractures', 'type': 'PROCEDURE', 'description': 'Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw', 'armGroupLabels': ['group (1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Mahmoud Mohamed Mohamed Hamadouh', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-06-22', 'type': 'RELEASE'}, {'date': '2023-03-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mahmoud Mohamed Mohamed Hamadouh, resident doctor, Sohag University'}}}}