Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 8:13 PM
Study NCT ID:
NCT01156766
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2010-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metaphyseal Distal Radius Fractures
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': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2010-07-02', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)', 'timeFrame': 'preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths'}], 'secondaryOutcomes': [{'measure': 'PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)', 'timeFrame': '2 weeks, 5 weeks, 3, 6 and 12 months'}, {'measure': "Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)", 'timeFrame': '5 weeks, 3, 6 and 12 months'}, {'measure': 'Grip and pinch strength (5 weeks, 3, 6 and 12 months)', 'timeFrame': '5 weeks, 3, 6 and 12 months'}]}, 'conditionsModule': {'keywords': ['Fracture', 'Radius', 'Osteosynthesis', 'Metaphyseal', 'Pinning', 'Locking anterior plate'], 'conditions': ['Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)']}, 'descriptionModule': {'briefSummary': 'The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.\n\nThe aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.', 'detailedDescription': 'Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.\n\nThe availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.\n\nThese clinical facts need of course to be validated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)\n* age 60 years or older\n\nExclusion Criteria:\n\n* open fracture\n* fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3\n* polytraumatized patient\n* fractures older than 15 days\n* infection of the operating site\n* previous osseous disease'}, 'identificationModule': {'nctId': 'NCT01156766', 'briefTitle': 'Metaphyseal Distal Radius Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture', 'orgStudyIdInfo': {'id': 'CHU-0077'}}, 'armsInterventionsModule': {'interventions': [{'name': '- locking anterior plate', 'type': 'DEVICE', 'description': 'The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.\n\nThe aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Stéphane DESCAMPS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker SA', 'class': 'INDUSTRY'}, {'name': 'Polyclinique du Parc Rambot', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}