Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01742650
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures
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': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-12-02', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malreduction of the tibiofibular joint in the intraoperative computed tomography', 'timeFrame': '2 years', 'description': 'Malreduction in the tibiofibular joint is assessed post op from the intraoperative computed tomography. Both ankles are imaged and difference at least 2 mm is assessed to be significant'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome one year after the injury', 'timeFrame': '2 year', 'description': 'Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 2-year of follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ankle; fracture; syndesmosis;'], 'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '25769201', 'type': 'DERIVED', 'citation': 'Kortekangas T, Savola O, Flinkkila T, Lepojarvi S, Nortunen S, Ohtonen P, Katisko J, Pakarinen H. A prospective randomised study comparing TightRope and syndesmotic screw fixation for accuracy and maintenance of syndesmotic reduction assessed with bilateral computed tomography. Injury. 2015;46(6):1119-26. doi: 10.1016/j.injury.2015.02.004. Epub 2015 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are consecutively included into the study. The tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the injury.', 'detailedDescription': 'The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Screw fixation is widely and mostly used transfixation but suture-button is also shown to be a biomechanically stable and probably more physiologic transfication method. It is shown that even 50 % of the syndesmosis srews and thus fibulas are in malposition. With more physiologic suture-button transfixation this malposition is thought to be less commmon. There is no studies comparing screw and suture-button syndesmosis transfixation methods in AO/OTA Weber C ankle fracture patients.\n\nOur hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition assessed in the intraoperative computed tomography. Malposition is assessed to present if difference between fractured and non-fractured side is at least 2 mm in the tibiofibular joint. Thus, the sample size is assessed to be 19 patients per group (alpha=0.05, Beta=0.2, 20% drop out).\n\nAll skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are included into the study. Exclusion criteria are previous ankle fracture, concomitant tibial fracture, diabetes with peripheral neuropathy, pathological fracture or inadequate co-operation.\n\nAfter bony fixation the tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). An intraoperative computed tomography is imaged from the both ankles of all patients. The operation is continued with six weeks casting without weight-bearing.\n\nClinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AO/OTA Weber C ankle fracture, operation within 7 days from the injury\n\nExclusion Criteria:\n\n* Bilateral or previous ankle fracture, tibial shaft fracture, diabetes wiht polyneuropathy, inadequate co-operation'}, 'identificationModule': {'nctId': 'NCT01742650', 'briefTitle': 'Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures. A Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'OYS-7-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Screw fixation', 'description': '3,5mm fully threaded cortical screw transfixation of syndesmosis', 'interventionNames': ['Procedure: Screw fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TightRope', 'description': 'TightRope transfixation of syndesmosis', 'interventionNames': ['Procedure: TightRope']}], 'interventions': [{'name': 'Screw fixation', 'type': 'PROCEDURE', 'description': '3,5mm fully threaded cortical screw transfixation of syndesmosis', 'armGroupLabels': ['Screw fixation']}, {'name': 'TightRope', 'type': 'PROCEDURE', 'otherNames': ['Tightrope Arthrex'], 'description': 'TightRope transfixation of syndesmosis', 'armGroupLabels': ['TightRope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Tero HJ Kortekangas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Harri Pakarinen', 'investigatorAffiliation': 'University of Oulu'}}}}