Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06234358
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Carried Out in Patients Operated With Calcanail®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate (revision)', 'timeFrame': '12 months', 'description': 'This objective will be evaluated according to the revision rate in the study'}], 'secondaryOutcomes': [{'measure': 'AOFAS score: American Orthopaedic Foot & Ankle Society Score', 'timeFrame': '12 months', 'description': 'performance / 100 points represent an "excellent" result and the minimal score was 0'}, {'measure': 'Bone consolidation', 'timeFrame': '4 months', 'description': 'Visible on X-ray after surgery'}, {'measure': 'Emergent adverse event', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcaneus Fracture', 'Calcaneus Deformity of Foot', 'Arthrosis; Localized']}, 'descriptionModule': {'briefSummary': 'This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.\n\nThe primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.\n\nThis is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.\n\n84 patients will be included in the study.', 'detailedDescription': 'The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient operated with the studied device between the 01/01/2012 and 01/01/2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient operated with the studied device between the 01/01/2012 and 01/01/2020.\n2. Patient over 18 years old\n3. Patient who has received informed information and does not object to the collection of their data in this study.\n\nExclusion Criteria:\n\nPatient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.'}, 'identificationModule': {'nctId': 'NCT06234358', 'briefTitle': 'A Clinical Study Carried Out in Patients Operated With Calcanail®', 'organization': {'class': 'INDUSTRY', 'fullName': 'FH ORTHO'}, 'officialTitle': 'A Retrospective Observational Clinical Study Carried Out in Patients Operated With Calcanail® in Order to Evaluate the Safety and Performance of the Device', 'orgStudyIdInfo': {'id': '2017-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Calcanail cohort', 'description': 'Patients implanted with medical device under study between January 2012 and January 2020.', 'interventionNames': ['Device: osteosynthesis']}], 'interventions': [{'name': 'osteosynthesis', 'type': 'DEVICE', 'description': 'calcaneus osteosynthesis is a surgical fixation of a displaced fracture of the calcaneous bone. The surgery is performed under general or regional anesthesia. A scar is made on the lateral side of the ankle below the lateral malleolus. The bone fragments are repositioned as anatomically as possible. They are fixed by a percutaneous nailing fastener.', 'armGroupLabels': ['Calcanail cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Julien LUCAS-HERNANDEZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FH ORTHO', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}