Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-05 @ 7:05 PM
Study NCT ID:
NCT03377205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-13
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Orthopaedic Foot and Ankle Society (AOFAS) score', 'timeFrame': '5 years', 'description': 'Functional outcome as assessed by AOFAS score (0-100)'}], 'secondaryOutcomes': [{'measure': 'Manchester-Oxford Foot questionnaire (MOxFQ)', 'timeFrame': '5 years', 'description': 'Patient reported outcome as assessed by MOxFQ (0-100)'}, {'measure': 'Olerud and Molander Score (OMS)', 'timeFrame': '5 years', 'description': 'Patient reported outcome as assessed by OMS (0-100)'}, {'measure': 'EuroQol-5d (Eq-5d)', 'timeFrame': '5 years', 'description': 'Patient reported quality of life as assessed by Eq-5d index score'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': '5 years', 'description': 'VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best'}, {'measure': 'Fracture reduction as assessed by CT scans', 'timeFrame': '3 months', 'description': 'Number of patients with good, fair or poor fracture reduction'}, {'measure': 'Malunion as assessed by CT scans', 'timeFrame': '5 years', 'description': 'Number of patients with malunion'}, {'measure': 'Nonunion as assessed by CT scans', 'timeFrame': '5 years', 'description': 'Number of patients with nonunion'}, {'measure': 'Osteoarthritis as assessed by CT scans', 'timeFrame': '5 years', 'description': 'Number of patients with osteoarthritis assessed according to the criteria by McLennan et al'}, {'measure': 'Infection', 'timeFrame': '3 months', 'description': 'Number of patients with wound infection or deep infection'}, {'measure': 'Delayed wound healing', 'timeFrame': '3 months', 'description': 'Number of patients with delayed wound healing'}, {'measure': 'Other complications', 'timeFrame': '5 years', 'description': 'Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankle Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.', 'detailedDescription': 'Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).\n* Operable with both methods of surgery within 3 weeks after injury.\n* Men and women ≥ 60 yoa.\n\nExclusion Criteria:\n\n* Prior injury or pathology with reduced ankle function.\n* Other acute foot/ankle/leg injury that will affect ankle function.\n* Fracture of the posterior malleolus that need fixation.\n* Injury / pathology that may affect rehabilitation.\n* Open fracture.\n* Inoperable patient.\n* Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.'}, 'identificationModule': {'nctId': 'NCT03377205', 'briefTitle': 'Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.', 'orgStudyIdInfo': {'id': '2016/137 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plate', 'description': 'Compression screws and neutralization plate.', 'interventionNames': ['Device: Compression screws and neutralization plate']}, {'type': 'EXPERIMENTAL', 'label': 'Intramedullary nail', 'description': 'Acumed Fibular Rod System', 'interventionNames': ['Device: Acumed Fibular Rod System']}], 'interventions': [{'name': 'Compression screws and neutralization plate', 'type': 'DEVICE', 'description': 'Open reduction and internal fixation with screws and plate', 'armGroupLabels': ['Plate']}, {'name': 'Acumed Fibular Rod System', 'type': 'DEVICE', 'description': 'intramedullary nailing of fibula', 'armGroupLabels': ['Intramedullary nail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Elisabeth E Husebye, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ostfold Hospital Trust', 'class': 'OTHER'}, {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Elisabeth Ellingsen Husebye', 'investigatorAffiliation': 'Oslo University Hospital'}}}}