Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02336035
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2015-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quick disabilities of the arm, shoulder and hand; Quick-DASH', 'timeFrame': '1 year', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Quick DASH', 'timeFrame': '3 and 6 months; 2 and 5 years', 'description': 'Questionnaire'}, {'measure': 'Patient rated wrist evaluation (PRWE)', 'timeFrame': '3, 6 and 12 months; 2 and 5 years', 'description': 'PRWE, Questionnaire'}, {'measure': 'Grip strength', 'timeFrame': '3, 6 and 12 months; 2 and 5 years', 'description': 'score'}, {'measure': 'Range of motion', 'timeFrame': '3, 6 and 12 months; 2 and 5 years', 'description': 'score'}, {'measure': 'Over all satisfaction', 'timeFrame': '6 weeks; 3, 6 and 12 months; 2 and 5 years', 'description': 'Over all satisfaction with hand function, numeric scale 0-10'}, {'measure': 'Complications', 'timeFrame': '6 weeks; 3, 6 and 12 months; 2 and 5 years', 'description': 'Registration of complications'}, {'measure': 'X-ray, wrist', 'timeFrame': '6 weeks; 3 and 12 months; 2 and 5 years', 'description': 'Radial shortening, dorsal tilt, intraarticular step-off'}, {'measure': 'EQ-5d (EuroQol)', 'timeFrame': '6 weeks; 3, 6 and 12 months; 2 and 5 years', 'description': 'Questionnaire'}, {'measure': 'Registration of need for assistance in daily life', 'timeFrame': '6 weeks; 3, 6 and 12 months; 2 and 5 years', 'description': 'Registration of need for assistance in daily life to register costs generated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Distal Radius Fracture']}, 'descriptionModule': {'briefSummary': 'Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.', 'detailedDescription': 'The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.\n\nThe investigators are planning a non-inferiority design.\n\nThe current study will test the following null hypothesis:\n\nIn patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.\n\nThe investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AO/OTA class A- and C-fractures\n* Age \\> 65 years\n* Unacceptable primary reduction or redislocation \\< 20 days post-injury with at least one of the following findings:\n* dorsal angulation \\> 10 degrees\n* radial shortening \\> 3 mm\n* intraarticular step-off \\> 2 mm\n* Ability to sign an informed consent\n* Acute fracture, inclusion within 20 days from injury.\n* Ability to reconstruct the articular surface with a volar locking plate\n\nExclusion Criteria:\n\n* Volar angulated fractures and AO type B\n* Associated diseases contraindicating surgery\n* Mental impairment, nursery home patient\n* Earlier wrist injury\n* Pathological fractures\n* Open fractures (\\>Gustilo-Anderson I) or damaged soft tissue\n* Drug abuse\n* Concomitant injuries that might affect outcome\n* Congenital anomaly of affected extremity\n* Median nerve compression that requires acute operation\n* Foreign language\n* Tourists'}, 'identificationModule': {'nctId': 'NCT02336035', 'acronym': 'DROC', 'briefTitle': 'Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2014 3830 RCT radius 65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Cast immobilization', 'description': 'Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain.\n\nBoth groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.'}, {'type': 'EXPERIMENTAL', 'label': 'Operation', 'description': 'Operation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain.\n\nBoth groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.', 'interventionNames': ['Procedure: Volar plate']}], 'interventions': [{'name': 'Volar plate', 'type': 'PROCEDURE', 'otherNames': ['Volar locking plate', 'VLP'], 'description': 'Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate', 'armGroupLabels': ['Operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0586', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jan Erik Madsen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sondre Stafsne Hassellund', 'investigatorAffiliation': 'Oslo University Hospital'}}}}