Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01431560
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-08', 'studyFirstSubmitDate': '2011-09-02', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Orthopaedic Foot and Ankle Society(AOFAS) score', 'timeFrame': '3 months, 6 months, 1 year', 'description': 'change from baseline(3 months after surgery)'}], 'secondaryOutcomes': [{'measure': 'Short Musculoskeletal Functional Assessment(SMFA) scale', 'timeFrame': '3 months, 6 months, 1 year', 'description': 'change from baseline (3 months after surgery)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ankle', 'metallic', 'biodegradable', 'Freedom'], 'conditions': ['Ankle Fracture']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* skeletally mature subjects (≥16 years old) with unilateral ankle fractures\n\nExclusion Criteria:\n\n* subjects less than 16 years old,\n* subjects not followed up at this hospital,\n* multiple injuries,\n* bilateral ankle fractures,\n* open fractures,\n* pathologic fractures,\n* concomitant tibial shaft fractures,\n* previous history of immobilization due to significant injury or a fracture of either ankle,\n* significant peripheral neuropathy,\n* soft tissue infection in the region on either injured ankle,\n* or inability to complete the study protocol'}, 'identificationModule': {'nctId': 'NCT01431560', 'briefTitle': 'Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Police Hospital'}, 'officialTitle': 'Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants', 'orgStudyIdInfo': {'id': 'National Police Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'metallic implant', 'description': 'fixation of the ankle fracture with metallic implants', 'interventionNames': ['Device: fixation of the ankle fracture (Solco )']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'biodegradable implant', 'description': 'fixation of the ankle fracture with Freedom plate and screws', 'interventionNames': ['Device: fixation of the ankle fracture (Freedom)']}], 'interventions': [{'name': 'fixation of the ankle fracture (Solco )', 'type': 'DEVICE', 'otherNames': ['metallic implant: Solco'], 'description': 'fixation with metallic implant', 'armGroupLabels': ['metallic implant']}, {'name': 'fixation of the ankle fracture (Freedom)', 'type': 'DEVICE', 'otherNames': ['biodegradable implant: Freedom'], 'description': 'fixation with biodegradable implant', 'armGroupLabels': ['biodegradable implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-708', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Police Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung Ho Noh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Police Hospital, Korea, Republic of'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Police Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Jung Ho Noh', 'investigatorAffiliation': 'National Police Hospital'}}}}