Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 8:02 PM
Study NCT ID:
NCT01484366
Status:
TERMINATED
Last Update Posted:
2014-11-11
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}, {'id': 'D004595', 'term': 'Electroplating'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004572', 'term': 'Electrolysis'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Low enrollment. Treament no longer used by researchers.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-10', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant pain', 'timeFrame': '1 year', 'description': 'a visual analog scale (VAS) will be used to assess pain in the forearm'}], 'secondaryOutcomes': [{'measure': 're-operation rate to remove painful hardware', 'timeFrame': '1 year', 'description': 'repeat surgical intervention will be captured'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fractures of both radius and ulna'], 'conditions': ['Fractures of Radius and Ulna']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:\n\n1. a lower rate of implant pain\n2. a lower re-operation rate to remove painful hardware.', 'detailedDescription': 'This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diaphyseal fractures of both radius and ulna\n* Ulna fractures that are oblique or transverse\n* Fractures may be closed or Grade I-IIIA open\n* Patients must be over 18 and skeletally mature\n\nExclusion Criteria:\n\n* Children under the age of 18\n* Pregnancy\n* Comminuted ulna fractures\n* Those with associated bony elbow or wrist trauma\n* Elbow dislocation\n* Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)"}, 'identificationModule': {'nctId': 'NCT01484366', 'briefTitle': 'Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna', 'organization': {'class': 'NETWORK', 'fullName': 'Florida Orthopaedic Institute'}, 'officialTitle': 'Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna', 'orgStudyIdInfo': {'id': 'BBFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intramedullary nailing and plating', 'description': 'intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures', 'interventionNames': ['Procedure: intramedullary nailing and plating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'plating', 'description': 'plating of both the radius and ulna in the treatment of both bone forearm fractures', 'interventionNames': ['Procedure: plating']}], 'interventions': [{'name': 'intramedullary nailing and plating', 'type': 'PROCEDURE', 'otherNames': ['forearm fractures'], 'description': 'Surgical intramedullary nailing of the ulna and plating of the radius', 'armGroupLabels': ['intramedullary nailing and plating']}, {'name': 'plating', 'type': 'PROCEDURE', 'otherNames': ['Forearm fractures'], 'description': 'Surgical plating of both bonforearm fractures', 'armGroupLabels': ['plating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'St Josephs Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Roy Sanders, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Orthopaedic Institute', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}