Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 11:32 PM
Study NCT ID:
NCT01035359
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2009-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraarticular Distal Radius Fractures, X-fix or Volar Fixation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016267', 'term': 'External Fixators'}], 'ancestors': [{'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-12', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'A secondary outcome is the degree of malalignment on the x-ray of the injured wrist.', 'timeFrame': '12 months'}, {'measure': 'A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radius', 'fracture', 'wrist', 'external', 'fixation', 'volar', 'plate', 'DASH', 'PRWE'], 'conditions': ['Dorsally Displaced Intraarticular Distal Radius Fractures', 'Age 50 - 74 for Females or 60-74 for Males', 'Low Energy Trauma']}, 'descriptionModule': {'briefSummary': 'Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.', 'detailedDescription': 'This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female 50-74 years or male 60-74 years\n* Dorsally displaced intraarticular distal radius fracture\n* Dorsal angulation \\>20 degrees measured from the plane perpendicular to the radius axis\n* Low energy trauma\n* Injury \\<72 hours when diagnosed\n* Patient independent of help for ADL\n\nExclusion Criteria:\n\n* Earlier dysfunction in any wrist\n* Other major injuries\n* Rheumatoid arthritis or other systemic joint disease\n* Dementia or severe psychiatric disease\n* Severe medical condition making general anesthesia a major risk'}, 'identificationModule': {'nctId': 'NCT01035359', 'briefTitle': 'Intraarticular Distal Radius Fractures, X-fix or Volar Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Dorsally Displaced Intraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'DRF intra'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'external fixation', 'description': 'Operation with external fixation and optional addition of k-wire', 'interventionNames': ['Procedure: External fixation']}, {'type': 'EXPERIMENTAL', 'label': 'Volar plate', 'description': 'Operation with a Synthes volar two column plate (TCP)', 'interventionNames': ['Procedure: Volar plate']}], 'interventions': [{'name': 'External fixation', 'type': 'PROCEDURE', 'otherNames': ["Stryker's Hoffman external fixation"], 'description': 'Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)', 'armGroupLabels': ['external fixation']}, {'name': 'Volar plate', 'type': 'PROCEDURE', 'otherNames': ['Synthes Two Column Plate (TCP)'], 'description': 'Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.', 'armGroupLabels': ['Volar plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Stockholm South Hospital Department of Orthopeadic Surgery', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, Senior consultant orthopaedic surgeon', 'investigatorFullName': 'Sari Ponzer', 'investigatorAffiliation': 'Karolinska Institutet'}}}}