Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-30 @ 2:56 PM
Study NCT ID:
NCT04655768
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm 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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Related Wrist Evaulation', 'timeFrame': '12-24 months post intervention', 'description': 'PRWE, ROM investigation'}], 'secondaryOutcomes': [{'measure': 'ROM', 'timeFrame': '12-24 months post intervention', 'description': 'PRWE, ROM, Investigation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radius fracture, clinical outcome'], 'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': "Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment.\n\nA randomized prospective trial is palnned", 'detailedDescription': 'Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment.\n\nPrimary aim is PRWE, secondary ROM as well as power and DASH score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radius Fractures C1-C2\n* age over 70\n\nExclusion Criteria:\n\n* demetia\n* collateral damages\n* age \\< 70'}, 'identificationModule': {'nctId': 'NCT04655768', 'briefTitle': 'Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kepler University Hospital'}, 'officialTitle': 'Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients', 'orgStudyIdInfo': {'id': 'KUK-UNF-20-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operative Arm', 'description': 'Radius fractures C1/C2 treated by palmar plate fixation', 'interventionNames': ['Device: Palmar Plate Fixation']}, {'type': 'NO_INTERVENTION', 'label': 'Conservative Arm', 'description': 'Radius Fractures C1/C2 treated by cast fixation'}], 'interventions': [{'name': 'Palmar Plate Fixation', 'type': 'DEVICE', 'description': 'Patients are treated by surgery (palmar plate)', 'armGroupLabels': ['Operative Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stefan M Froschauer, MD', 'role': 'CONTACT', 'email': 'stefan.froschauer@kepleruniklinikum.at', 'phone': '004373278061020'}, {'name': 'Stefan M Froschauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Haslhofer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'centralContacts': [{'name': 'Stefan M Froschauer, MD', 'role': 'CONTACT', 'email': 'stefan.froschauer@kepleruniklinikum.at', 'phone': '+4373278061020'}], 'overallOfficials': [{'name': 'Stefan M Froschauer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kepler University Hospital Linz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kepler University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}