Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-30 @ 7:21 AM
Study NCT ID:
NCT01072760
Status:
COMPLETED
Last Update Posted:
2010-02-22
First Post:
2010-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001864', 'term': 'Bone Wires'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-19', 'studyFirstSubmitDate': '2010-02-12', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The digits were assessed for skin necrosis, skin breakdown, infection.', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': "The patients rated their pain experience by a visual analogue scale. The results were graded by Crawford's criteria.", 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mallet finger', 'extensor tendon', 'Kirschner wire', 'Fracture Fixation'], 'conditions': ['Bony Mallet Finger']}, 'referencesModule': {'references': [{'pmid': '19880893', 'type': 'RESULT', 'citation': 'Lee YH, Kim JY, Chung MS, Baek GH, Gong HS, Lee SK. Two extension block Kirschner wire technique for mallet finger fractures. J Bone Joint Surg Br. 2009 Nov;91(11):1478-81. doi: 10.1302/0301-620X.91B11.22478.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this report is to describe a new surgical technique for the treatment of bony mallet finger which involves the application of both Kirschner wire and pull-out wire fixation. It is believed to decrease the risk of the complications.', 'detailedDescription': 'From May 2003 to December 2008, we used Kirschner wire and pull-out wire fixation to carry out 54 closed bony mallet finger in 54 patients. The bony mallet finger was applicated both Kirschner wire and pull-out wire fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. bony mallet finger;\n2. patient had failed trials of nonsurgical treatment;\n3. fracture involving more than 1/3 of the joint surface;\n4. fragment displacement or subluxation of the DIP joint.\n\nExclusion Criteria:\n\n1. tendinous mallet finger;\n2. success of nonsurgical treatment;\n3. comminuted fracture;\n4. fracture involving at or less than 1/3 of the joint surface which could be successfully replaced with nonsurgical treatment.'}, 'identificationModule': {'nctId': 'NCT01072760', 'briefTitle': 'Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Qinhuangdao'}, 'officialTitle': 'Kirschner Wire and Pull-out Wire Fixation for the Treatment of Bony Mallet Finger', 'orgStudyIdInfo': {'id': 'QHD201002'}, 'secondaryIdInfos': [{'id': 'QHD20010201', 'type': 'OTHER', 'domain': 'The second hospital of Qinhuangdao'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'K wire', 'interventionNames': ['Procedure: K wire']}], 'interventions': [{'name': 'K wire', 'type': 'PROCEDURE', 'otherNames': ['stainless steel wire'], 'description': 'Mallet finger treatment', 'armGroupLabels': ['K wire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066600', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'The second hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Sumin Wen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Qinhuangdao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Qinhuangdao', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xu Zhang', 'oldOrganization': 'The Second Hospital of Qinhuangdao'}}}}