Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT01234493
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2010-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Syndesmotic Injury and Fixation in Supination-External (SE) 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': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olerud-Molander score', 'timeFrame': 'minimum one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ankle; fracture; syndesmosis;'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures. Our hypothesis was that syndesmotic ligaments heal at the proper length after malleolar reduction and that syndesmotic transfixation is not needed in supination-external rotation fracture types.', 'detailedDescription': 'A prospective randomized study comparing syndesmotic transfixation to no fixation in AO/OTA Weber B-type ankle fractures was designed. To show a clinically significant difference (Olerud-Molander ankle score 20%, standard deviation (SD) 24 points, from our previous study) between the groups, the sample size was estimated (α=0.05, β=0.2, 20% drop out) to be 30 patients per group.\n\nAll skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital were considered eligible for the present study. Exclusion criteria were bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.\n\nAfter bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixation with 3.5-mm tricortical screws or no syndesmotic fixation.\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': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital\n\nExclusion Criteria:\n\n* Bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.'}, 'identificationModule': {'nctId': 'NCT01234493', 'briefTitle': 'Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Syndesmotic Injury and Fixation in SE Ankle Fractures: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'SE4rand1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fixation', 'description': 'Syndesmosis fixation with one 3.5mm fully threaded screw', 'interventionNames': ['Procedure: fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no fixation', 'description': 'No syndesmosis fixation', 'interventionNames': ['Procedure: no fixation']}], 'interventions': [{'name': 'fixation', 'type': 'PROCEDURE', 'description': 'Syndesmosis fixation with one 3.5mm fully threaded three cortical screw', 'armGroupLabels': ['fixation']}, {'name': 'no fixation', 'type': 'PROCEDURE', 'description': 'No syndesmosis fixation.', 'armGroupLabels': ['no fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90650', 'city': 'Oulu', 'state': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Harri J Pakarinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgeon', 'investigatorFullName': 'Harri Pakarinen', 'investigatorAffiliation': 'University of Oulu'}}}}