Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-28 @ 10:22 PM
Study NCT ID:
NCT01818466
Status:
WITHDRAWN
Last Update Posted:
2016-06-28
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Tibiotalar Arthrodesis With Blade Plate Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Dr. Higgins does not have a sub-investigator that can complete the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome Questionnaires relating to the patients current condition', 'timeFrame': '1 Year after Surgery', 'description': 'These questionnaires will include the FAOS, FADI, SF-36, PromisCAT, SMFA, and the DRAM.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pilon Fracture', 'Arthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients whom have undergone anterior ankle arthrodesis with a blade plate construct, performed by a single surgeon, between January 2003 and July 2011 at the University of Utah or Primary Childrens Medical Center (PCMC) will be eligible for inclusion.\n\nExclusion Criteria:\n\n* Any patient who is not 18 years of age or older will not be eligible for the study.'}, 'identificationModule': {'nctId': 'NCT01818466', 'briefTitle': 'Anterior Tibiotalar Arthrodesis With Blade Plate Fixation', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Anterior Tibiotalar Arthrodesis With Blade Plate Fixation in Treatment of Post-traumatic Arthritis Secondary to Pilon Fracture', 'orgStudyIdInfo': {'id': '57171'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Higgins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Surgery Operations'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Thomas Higgins', 'investigatorAffiliation': 'University of Utah'}}}}