Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-29 @ 8:34 PM
Study NCT ID:
NCT00397995
Status:
UNKNOWN
Last Update Posted:
2006-11-10
First Post:
2006-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Undislocated Distal Both-Bone Forearm Fractures in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'lastUpdateSubmitDate': '2006-11-08', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pronation and supination'}], 'secondaryOutcomes': [{'measure': 'complications, function, esthetics, complains in daily living, X-rays'}]}, 'conditionsModule': {'keywords': ['Fracture', 'Forearm', 'Distal', 'Child', 'Treatment'], 'conditions': ['Fracture', 'Forearm', 'Distal', 'Child', 'Treatment']}, 'descriptionModule': {'briefSummary': 'We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.', 'detailedDescription': 'children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.\n\nAfter informed consent, a randomization between 2 kinds of cast will be done.\n\nOutpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both-bone forearm fracture\n* distal\n* undislocated\n* age \\< 16 years\n\nExclusion Criteria:\n\n* fracture older than 1 week\n* no informed consent\n* refracture\n* open fracture (Gustillo 2 and 3)\n* both fractures type torus'}, 'identificationModule': {'nctId': 'NCT00397995', 'briefTitle': 'Undislocated Distal Both-Bone Forearm Fractures in Children', 'organization': {'class': 'INDIV', 'fullName': 'Colaris, Joost, M.D.'}, 'officialTitle': 'Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.', 'orgStudyIdInfo': {'id': 'Colaris04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'above- or under elbow cast', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'joost w colaris, drs', 'role': 'CONTACT', 'email': 'joostcolaris@hotmail.com', 'phone': '0031642220265'}], 'facility': "Erasmus Medical Centre location Sophia Children's hospital", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'joost w colaris', 'role': 'CONTACT', 'email': 'joostcolaris@hotmail.com', 'phone': '0031642220265'}], 'facility': "HAGA, location Juliana Children's Hospital", 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'centralContacts': [{'name': 'joost w colaris, drs', 'role': 'CONTACT', 'email': 'joostcolaris@hotmail.com', 'phone': '0031642220265'}], 'overallOfficials': [{'name': 'joost w Colaris, drs', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colaris, Joost, M.D.', 'class': 'INDIV'}}}}