Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT02154620
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2014-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2014-05-02', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient related wrist evaluation (PRWE)', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient related wrist evaluation (PRWE)', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Distal radius fracture', 'wrist fracture', 'volar plate', 'surgical treatment', 'plaster immobilisation'], 'conditions': ['Distal Radius Fracture']}, 'referencesModule': {'references': [{'pmid': '35549696', 'type': 'DERIVED', 'citation': 'Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.'}]}, 'descriptionModule': {'briefSummary': 'Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.\n\nAn additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.\n\nA health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.\n* Low energy injury\n* Patient 70 years old or older\n* 72 hours or less since injury at time of diagnosis\n* Patient registered in the Stockholm region\n* Patient understands spoken and written swedish\n\nExclusion Criteria:\n\n* Intraarticular displacement in radiocarpal joint of more than 1 mm\n* Ulna fractured proximal to the base of the styloid process of ulna\n* Earlier unilateral functional impairment of hand/wrist\n* Injury to tendon, nerve or skin besides the fracture\n* Rheumatoid arthritis or other severe systemic joint disease\n* Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)\n* Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle\n* Medical illness that makes general anesthesia impossible'}, 'identificationModule': {'nctId': 'NCT02154620', 'acronym': '70', 'briefTitle': 'Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Plaster cast', 'description': 'The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist'}, {'type': 'EXPERIMENTAL', 'label': 'Volar plate', 'description': 'The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.', 'interventionNames': ['Procedure: Volar plate', 'Device: Synthes TCP volar plate']}], 'interventions': [{'name': 'Volar plate', 'type': 'PROCEDURE', 'otherNames': ['Synthes TCP volar plate for distal radius'], 'description': "An anatomically countoured volar plate is implanted through a Henry's incision.", 'armGroupLabels': ['Volar plate']}, {'name': 'Synthes TCP volar plate', 'type': 'DEVICE', 'armGroupLabels': ['Volar plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Orthopaedics, Stockholm South Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Anders Enocson, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sari Ponzer', 'investigatorAffiliation': 'Karolinska Institutet'}}}}