Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT07039695
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2025-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005599', 'term': 'Fractures, Ununited'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mayo Wrist Score', 'timeFrame': '3 months post-procedure', 'description': 'The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength. Mayo Wrist Score ranges from 0 to 100. Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.'}], 'secondaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder and Hand (DASH) score', 'timeFrame': '3 months post-procedure', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. The score is calculated on a scale score ranging from 0 (no disability) to 100 (most severe disability).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Union', 'Scaphoid', 'Non-Union Fracture', 'Herbert Screw', 'Volar Buttress Plate']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw.', 'detailedDescription': 'Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.\n\nNonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.\n\nA scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of a patient is between 20 years to 50 years.\n* Non-union or delayed union scaphoid wrist fracture (more than 3 months).\n* Closed fracture.\n* Patients without previous scaphoid surgery.\n* Patients without abnormal renal and/or liver functions.\n* Patients without hypocalcemia and/or vitamin D3 deficiency.\n\nExclusion Criteria:\n\n* Open fracture.\n* Patients with proximal or distal fracture of the scaphoid.\n* Patients with avascular necrosis of scaphoid.\n* Patients with mid-carpal arthritis or pan-carpal arthritis.\n* Patients with carpal instability.'}, 'identificationModule': {'nctId': 'NCT07039695', 'briefTitle': 'Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate', 'orgStudyIdInfo': {'id': '10-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volar buttress plate group', 'description': 'Patients will be treated by a volar buttress plate.', 'interventionNames': ['Procedure: Volar buttress plate']}, {'type': 'EXPERIMENTAL', 'label': 'Herbert screw group', 'description': 'Patients will be treated by Herbert screw.', 'interventionNames': ['Procedure: Herbert screw']}], 'interventions': [{'name': 'Volar buttress plate', 'type': 'PROCEDURE', 'description': 'Patients will be treated by a volar buttress plate.', 'armGroupLabels': ['Volar buttress plate group']}, {'name': 'Herbert screw', 'type': 'PROCEDURE', 'description': 'Patients will be treated by Herbert screw.', 'armGroupLabels': ['Herbert screw group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11795', 'city': 'Helwan', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Helwan University', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Orthopedic Surgery, Faculty of Medicine, Helwan University, Egypt.', 'investigatorFullName': 'Khaled Karam Abed El-Aleem Mohammed', 'investigatorAffiliation': 'Helwan University'}}}}