Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:31 AM
Study NCT ID:
NCT07440251
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological union', 'timeFrame': '24 Weeks', 'description': 'Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices).\n\nUnit of Measure: Number of Participants.'}], 'secondaryOutcomes': [{'measure': 'Mean Hand Grip Strength', 'timeFrame': '24 weeks', 'description': 'Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded.\n\nUnit of Measure: Kilograms.'}, {'measure': 'Range of Motion (ROM) of the affected joint (wrist)', 'timeFrame': '24 weeks', 'description': 'Clinical measurement of the degree of movement in the joint (flexion, extension, pronation, and supination) using a standard goniometer.\n\nUnit of Measure: Degrees.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal ulna fractures', 'Dual fixation'], 'conditions': ['Distal Ulna Fracture']}, 'descriptionModule': {'briefSummary': 'Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .\n\nDual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced distal ulna fractures either isolated or with associated distal radius fractures.\n* Unstable distal ulna fractures\n* Age group: \\[Adults aged 18 years and older\\].\n\nExclusion Criteria:\n\n* Open fractures with severe soft tissue injury (Gustilo type III).\n* Pathological fractures.\n* Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.'}, 'identificationModule': {'nctId': 'NCT07440251', 'briefTitle': 'Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm', 'orgStudyIdInfo': {'id': 'Soh-Med-26-2-1MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Distal ulna fractures', 'interventionNames': ['Procedure: Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm']}], 'interventions': [{'name': 'Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm', 'type': 'PROCEDURE', 'description': 'Evaluation of dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm.', 'armGroupLabels': ['Distal ulna fractures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of medicine sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mostafa Ali Hamed', 'role': 'CONTACT', 'email': 'mostafaalihamed97@gmail.com', 'phone': '+201006850240'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident , Orthopaedics and Traumatology Department', 'investigatorFullName': 'Mostafa Ali Hamed', 'investigatorAffiliation': 'Sohag University'}}}}