Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:16 AM
Study NCT ID:
NCT07320404
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2024-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arthroscopic Scaphoid Grafting Versus Open Grafting in Scaphoid Non Union
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups one with the arthroscopic grafting combined with percutaneous fixation, the second with opend grafting and fixation by K wires.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2024-07-21', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'union rate', 'timeFrame': '6 months', 'description': 'percentage of patients in each arm that achieve bony union'}, {'measure': 'time to union', 'timeFrame': '6 to 24 weeks', 'description': 'the time that patient take to achieve bony union'}, {'measure': 'wrist flexion and extension', 'timeFrame': 'preoperative, at 6 months and at 24 months', 'description': 'flexion and extension range of motion'}, {'measure': 'wrist radial and ulnar deviation', 'timeFrame': 'preoperative, at 6 months and at 24 months', 'description': 'radial and ulnar deviation range of motion'}, {'measure': 'grip strength', 'timeFrame': 'preoperative , at 6 months and at 24 months', 'description': 'the power of hand grip measured by dynamometer'}, {'measure': 'The disability of arm, shoulder and hand score (DASH score)', 'timeFrame': 'preoperative , at 6 months and at 24 months', 'description': 'a questionnaire to assess upper limb function from 0 to 100 where the lower the score means better outcome'}, {'measure': 'The Mayo modified wrist score', 'timeFrame': 'preoperative, at 6 months and at 24 months', 'description': 'A functional score that depends on the patients function and examination from 0 to 100 and the higher the score the higher the outcome'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '2 years post operative'}, {'measure': 'Degree of scaphoid hump back deformity correction', 'timeFrame': 'post operative after bony union up to 1 year', 'description': 'Radiological parameter thorough scapholunate angle'}, {'measure': 'Operative time', 'timeFrame': 'intraoperative', 'description': 'the duration of each operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scaphoid Fracture Non Union']}, 'referencesModule': {'references': [{'pmid': '26051763', 'type': 'BACKGROUND', 'citation': 'Jegal M, Kim JS, Kim JP. Arthroscopic Management of Scaphoid Nonunions. Hand Surg. 2015;20(2):215-21. doi: 10.1142/S0218810415400031.'}, {'pmid': '15513497', 'type': 'RESULT', 'citation': 'Munk B, Larsen CF. Bone grafting the scaphoid nonunion: a systematic review of 147 publications including 5,246 cases of scaphoid nonunion. Acta Orthop Scand. 2004 Oct;75(5):618-29. doi: 10.1080/00016470410001529.'}]}, 'descriptionModule': {'briefSummary': 'the investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient', 'detailedDescription': 'The treatment of scaphoid non union has no gold standard technique so in this study the investigators try to compare the arthroscopic and the open grafting techniques to determine the better technique to achieve union, time to union and the better functional outcomes including wrist range of motion and grip strength as a primary outcome and the secondary outcomes are the operative time, the complications and radiological correction of the hum-back deformity if present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scaphoid non-union cases\n* 16 years or older\n* males or females\n* independent from chronicity or non-union location and the investigators defined the non union as failure to reach scaphoid union up to 6 months\n\nExclusion Criteria:\n\n.Revision scaphoid non-union cases.\n\n* Previously operated wrist for any other pathology\n* Avascular necrosis (AVN) confirmed by intraoperative inspection.\n* Scaphoid non-union advanced collapse (SNAC) stage 2 and higher.\n* Any associated wrist pathology that required separate treatment surgical approach.'}, 'identificationModule': {'nctId': 'NCT07320404', 'briefTitle': 'Arthroscopic Scaphoid Grafting Versus Open Grafting in Scaphoid Non Union', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Arthroscopic Scaphoid Bone Graft Combined With Percutaneous Fixation Versus Open Scaphoid Fixation With Non Vascularized Graft in Scaphoid Non-union', 'orgStudyIdInfo': {'id': 'FAMSU MD 288/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arthroscopic A group', 'description': 'arthroscopic bone grafting combined with percutaneous K wires fixation for scaphoid non union patients', 'interventionNames': ['Procedure: Arthroscopic grafting and k wires fixation']}, {'type': 'EXPERIMENTAL', 'label': 'open O group', 'description': 'open volar or dorsal scaphoid grafting with K wires fixation for scaphoid non union patients', 'interventionNames': ['Procedure: open scaphoid grafting with K wires fixation']}], 'interventions': [{'name': 'Arthroscopic grafting and k wires fixation', 'type': 'PROCEDURE', 'description': 'Arthroscopic midrcarpal scaphoid non union debridment and iliac cancellous bone grafting with K wires fixation', 'armGroupLabels': ['arthroscopic A group']}, {'name': 'open scaphoid grafting with K wires fixation', 'type': 'PROCEDURE', 'description': 'open surgical volar or dorsal scaphoid non union site debridment and application of iliac bone graft and K wires fixation', 'armGroupLabels': ['open O group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed El-Mahy, prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}