Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 11:08 PM
Study NCT ID:
NCT04482868
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2020-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008283', 'term': 'Maintenance'}], 'ancestors': [{'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2020-07-19', 'studyFirstSubmitQcDate': '2020-07-19', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The modified Mayo wrist scoring system', 'timeFrame': '3 months', 'description': 'The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand', 'Wrist', 'Wounds and Injuries']}, 'referencesModule': {'references': [{'pmid': '29318360', 'type': 'BACKGROUND', 'citation': 'Yu Y, Cui H, Yang X, Yu X, Bai Y. A novel percutaneous achievement and maintenance of reduction and screw fixation for acute displaced scaphoid fractures: minimum two-year follow-up. Int Orthop. 2018 Aug;42(8):1911-1916. doi: 10.1007/s00264-018-3758-5. Epub 2018 Jan 10.'}, {'pmid': '18656774', 'type': 'BACKGROUND', 'citation': 'Merrell G, Slade J. Technique for percutaneous fixation of displaced and nondisplaced acute scaphoid fractures and select nonunions. J Hand Surg Am. 2008 Jul-Aug;33(6):966-73. doi: 10.1016/j.jhsa.2008.04.023.'}, {'pmid': '31543293', 'type': 'BACKGROUND', 'citation': 'Morsy M, Sabbagh MD, van Alphen NA, Laungani AT, Kadar A, Moran SL. The Vascular Anatomy of the Scaphoid: New Discoveries Using Micro-Computed Tomography Imaging. J Hand Surg Am. 2019 Nov;44(11):928-938. doi: 10.1016/j.jhsa.2019.08.001. Epub 2019 Sep 19.'}, {'pmid': '24651287', 'type': 'BACKGROUND', 'citation': 'Garcia RM, Ruch DS. Management of scaphoid fractures in the athlete: open and percutaneous fixation. Sports Med Arthrosc Rev. 2014 Mar;22(1):22-8. doi: 10.1097/JSA.0000000000000008.'}]}, 'descriptionModule': {'briefSummary': 'The scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. Long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. This study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute scaphoid fractures\n* Injury to surgery less than 7 days\n* Only one injured hand\n* Written informed consent to undergo the surgical procedure\n* Patients of either sex aged between 18 and 70 years\n\nExclusion Criteria:\n\n* Patients with vascular injuried requiring revascularization\n* Concomitant phalanx fractures or other injuries needing immobilization\n* Loss of skin substance requiring grafts or flaps\n* Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders\n* Smokers'}, 'identificationModule': {'nctId': 'NCT04482868', 'briefTitle': 'Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance', 'orgStudyIdInfo': {'id': '2017-09-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'open reduction group', 'interventionNames': ['Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance']}, {'type': 'EXPERIMENTAL', 'label': 'percutaneous group', 'interventionNames': ['Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance']}], 'interventions': [{'name': 'Percutaneous screw fixation through K-wire-assisted reduction and maintenance', 'type': 'PROCEDURE', 'description': 'Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance', 'armGroupLabels': ['open reduction group', 'percutaneous group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chunjie Liu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hebei Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Chunjie Liu', 'investigatorAffiliation': 'Hebei Medical University'}}}}