Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00704002
Status:
TERMINATED
Last Update Posted:
2013-03-29
First Post:
2008-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2008-06-23', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability of the Arm, Shoulder and Hand (DASH) questionnaire', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neck fracture of the fifth metacarpal', 'displacement', 'antegrade intramedullary splinting', 'conservative treatment'], 'conditions': ['Fifth Metacarpal Neck Fracture']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.', 'detailedDescription': 'The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* displaced neck fracture of the fifth metacarpal (at least 30° angulation)\n* isolated injury\n* age between 18 and 75 years\n* informed consent\n\nExclusion Criteria:\n\n* rotational displacement\n* open fracture\n* injury older than one week\n* treatment other than within this study\n* other relevant injuries of the upper extremities\n* other injury or disease of the hand\n* pregnancy\n* missing informed consent\n* incompliance\n* coagulopathy\n* allergy to metallic implants\n* Patients who have participated in any other device or drug clinical trial within the previous month'}, 'identificationModule': {'nctId': 'NCT00704002', 'acronym': 'CONFraM', 'briefTitle': 'Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal', 'orgStudyIdInfo': {'id': 'CONFraM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'antegrade intramedullary splinting', 'interventionNames': ['Procedure: antegrade intramedullary splinting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'conservative treatment', 'interventionNames': ['Procedure: conservative treatment']}], 'interventions': [{'name': 'antegrade intramedullary splinting', 'type': 'PROCEDURE', 'description': 'antegrade intramedullary splinting with 2 to 3 small K-wires', 'armGroupLabels': ['A']}, {'name': 'conservative treatment', 'type': 'PROCEDURE', 'description': 'conservative treatment with 2-finger splint for one week', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Department of Trauma and Hand Surgery', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Michael Schädel-Höpfner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}