Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 7:06 PM
Study NCT ID:
NCT01757951
Status:
SUSPENDED
Last Update Posted:
2022-11-02
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'ESTIMATED', 'count': 126}}, 'statusModule': {'whyStopped': 'Partly due to financial issues and changes in study staff work placements', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2012-12-21', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications and Harms', 'timeFrame': 'At two, four and 12 weeks, and at 2 years', 'description': 'Treatment related complications and harms (i.e. wound infection, re-operations, deep vein trombhosis, plaster sore, wound healing problems)'}], 'primaryOutcomes': [{'measure': 'Olerud-Molander Ankle Score', 'timeFrame': '2 years', 'description': 'A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function'}], 'secondaryOutcomes': [{'measure': 'The Foot and Ankle Outcome Score (FAOS)', 'timeFrame': '2 years', 'description': 'FAOS, 5 subscales from 0-100, with higher scores indicating better function'}, {'measure': 'A 100 mm Visual Analogue Scale for function and pain (VAS)', 'timeFrame': '2 years', 'description': 'Range from 0 to 100, with higher scores indicating more severe pain'}, {'measure': 'The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)', 'timeFrame': '2 years', 'description': '8 subscales from 0-100, with higher scores indicating better health-related quality of life'}, {'measure': 'Talocrural joint congruence', 'timeFrame': 'At two, four and 12 weeks, and at 2 years', 'description': 'Medial clear space \\< 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome.'}, {'measure': 'Fracture healing', 'timeFrame': '2 years', 'description': 'Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ankle', 'Fracture', 'medial malleolus', 'Osteosynthesis'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': "A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)\n* Age: 16 years or older\n* Voluntary\n* Operated within 7 days of the trauma\n* Able to walk unaided before the current trauma\n\nExclusion Criteria:\n\n* Peripheral neuropathy\n* Pilon fracture\n* Bilateral ankle fracture\n* Concomitant tibial fracture\n* Pathological fracture\n* Active infection around the ankle\n* A previous ankle fracture on either side\n* In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs\n* Inadequate co-operation\n* Permanent residence outside the catchment area of the study hospital'}, 'identificationModule': {'nctId': 'NCT01757951', 'briefTitle': 'Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OYSnilkka-RCT4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unimalleolar Fixation', 'description': 'Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.', 'interventionNames': ['Procedure: Unimalleolar fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bimalleolar Fixation', 'description': 'Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.', 'interventionNames': ['Procedure: Bimalleolar fixation']}], 'interventions': [{'name': 'Unimalleolar fixation', 'type': 'PROCEDURE', 'description': 'Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.', 'armGroupLabels': ['Unimalleolar Fixation']}, {'name': 'Bimalleolar fixation', 'type': 'PROCEDURE', 'description': 'Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.', 'armGroupLabels': ['Bimalleolar Fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Harri J Pakarinen, MD, PhD, AP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pohjois-Pohjanmaan sairaanhoitopiiri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Harri Pakarinen', 'investigatorAffiliation': 'University of Oulu'}}}}