Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-29 @ 2:08 PM
Study NCT ID:
NCT04950361
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2021-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Patients With Talocalcaneal Coalitions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CT', 'timeFrame': 'pre-surgery', 'description': 'computerized tomography scan'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'pre-surgery', 'description': 'magnetic resonance imaging'}, {'measure': 'AFOAS', 'timeFrame': 'pre-surgery, one year after sugery', 'description': 'he American Orthopaedic Foot \\& Ankle Society score'}, {'measure': 'Tegner', 'timeFrame': 'pre-surgery, one year after sugery', 'description': 'the Tegner score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Talocalcaneal Coalition']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to develop a new classification system based on the articular facets involved to cover all coalitions and guide operative planning.', 'detailedDescription': 'Patients were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021. We classified the coalition into four main types according to the shape and nature of the coalition: I, inferiorly overgrown talus or superiorly overgrown calcaneus; II, both talus and calcaneus overgrew; III, coalition with an accessory ossicle; (I-III types are non-osseous coalition) IV, complete osseous coalition. Then each type was further divided into three subtypes according to the articular facets involved. A, the coalition involving the anterior facets; M, the coalition involving the middle facets, and P, the coalition involving the posterior facets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as talocalcaneal coalition by CT or MRI at the outpatient\n* Underwent arthroscopic talocalcaneal coalition resection due to failure of conservative treatment\n\nExclusion Criteria:\n\n* The affected side underwent other foot and ankle operations\n* Combined with other ankle diseases\n* Refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT04950361', 'briefTitle': 'Follow-up of Patients With Talocalcaneal Coalitions', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Follow-up of Patients With Talocalcaneal Coalitions', 'orgStudyIdInfo': {'id': 'M2020197'}}, 'armsInterventionsModule': {'interventions': [{'name': 'talocalcaneal coalition', 'type': 'OTHER', 'description': 'patients with talocalcaneal coalition'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Qinwei Guo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}