Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT00679393
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Fixation or Fusion of Calcaneal Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018460', 'term': 'Fractures, Comminuted'}, {'id': 'D057072', 'term': 'Intra-Articular Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050939', 'term': 'Gene Fusion'}], 'ancestors': [{'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General Health Survey - SF-36', 'timeFrame': '6 months, 12 months, and 24 months'}], 'secondaryOutcomes': [{'measure': 'Validated Visual Analogue Scale', 'timeFrame': '6 months, 12 months, and 24 months'}, {'measure': 'Musculoskeletal Function Assessment', 'timeFrame': '6 months, 12 months, and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Calcaneus', 'Intra-articular fracture', 'open reduction internal fixation', 'primary subtalar fusion'], 'conditions': ['Fractures, Comminuted', 'Fracture Fixation, Internal']}, 'descriptionModule': {'briefSummary': 'A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '59 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with Sanders IV displaced intra-articular calcaneal fracture\n* males and females aged 16-59 inclusive\n* ability to provide informed consent\n* available for follow-up for at least 2 years after injury\n\nExclusion Criteria:\n\n* medical contraindications to surgery\n* previous calcaneal pathology (infection, tumor, etc)\n* co-existent foot or ipsilateral lower limb injury\n* open calcaneal fracture\n* injury greater than 3 weeks old\n* head injured patients\n* inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system\n* inability to comply with advice to diminish smoking after the injury\n* metal allergy\n* extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon\n* any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion'}, 'identificationModule': {'nctId': 'NCT00679393', 'acronym': 'Sanders IV', 'briefTitle': 'Comparative Study of Fixation or Fusion of Calcaneal Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus', 'orgStudyIdInfo': {'id': '17526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fix', 'description': 'Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)', 'interventionNames': ['Procedure: Open reduction internal fixation']}, {'type': 'OTHER', 'label': 'Fuse', 'description': 'Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).', 'interventionNames': ['Procedure: Fusion']}], 'interventions': [{'name': 'Open reduction internal fixation', 'type': 'PROCEDURE', 'description': 'Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).', 'armGroupLabels': ['Fix']}, {'name': 'Fusion', 'type': 'PROCEDURE', 'description': 'Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)', 'armGroupLabels': ['Fuse']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Halifax Infirmary, QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Richard E Buckley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}, {'name': 'AO North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Section of Orthopaedics, Department of Surgery', 'investigatorFullName': 'Richard Buckley', 'investigatorAffiliation': 'University of Calgary'}}}}