Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT01139528
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2010-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quick-DASH', 'timeFrame': '6 weeks, 3 months, 1 year, 2 years', 'description': 'Validated hand function score'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '6 weeks, 3 months, 1 year, 2 years', 'description': 'VAS scale'}, {'measure': 'Pain', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years', 'description': 'VAS scale'}, {'measure': 'Eq-5d', 'timeFrame': '6 weeks, 3 months, 1 year, 2 years', 'description': 'Validated quality of life score'}, {'measure': 'Complications', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years', 'description': 'All complications are noted'}, {'measure': 'Sick-leave', 'timeFrame': '1 week, 6 weeks, 3 months (1 year, 2 years)', 'description': 'Days of sick-leave off work'}, {'measure': 'Range of motion in the joints in the 5th finger measured by hand therapist', 'timeFrame': '3 months, 1 year, 2 years', 'description': 'total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint'}, {'measure': 'Grip strength', 'timeFrame': '3 months, 1 year, 2 years', 'description': 'Compared to the non-injured hand'}, {'measure': 'Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand', 'timeFrame': '6 weeks, 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fracture', '5th metacarpal bone', 'Bouquet pinning', 'Fractures of the neck of the 5th metacarpal bone'], 'conditions': ['Fractures of the Neck']}, 'referencesModule': {'references': [{'pmid': '23060463', 'type': 'DERIVED', 'citation': 'Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone\n\nExclusion Criteria:\n\n* Less than 30 degrees of volar angulation in the fracture\n* rotational deformity\n* pseudoclawing\n* intra-articular involvement\n* ad latus displacement more than one half of a bone width\n* concomitant fractures or soft tissue damage\n* admittance more than 14 days after injury\n* non-compliant patient (language, drugs, tourist)\n* patient who refuses to participate in the study'}, 'identificationModule': {'nctId': 'NCT01139528', 'acronym': 'MC-studien', 'briefTitle': 'Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'FASUUS 1529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative treatment', 'description': 'Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins', 'interventionNames': ['Procedure: Bouquet pinning of the 5th metacarpal bone']}, {'type': 'NO_INTERVENTION', 'label': 'Conservative treatment', 'description': 'No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping'}], 'interventions': [{'name': 'Bouquet pinning of the 5th metacarpal bone', 'type': 'PROCEDURE', 'description': 'The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position', 'armGroupLabels': ['Operative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lars Nordsletten, Prof. MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Akershus', 'class': 'OTHER'}, {'name': 'Asker & Baerum Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant orthopaedic surgeon', 'investigatorFullName': 'Ida Neergård Sletten', 'investigatorAffiliation': 'Oslo University Hospital'}}}}