Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 7:45 PM
Study NCT ID:
NCT06338566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bony outcome of transcalcaneal nailing', 'timeFrame': 'up to 6 months', 'description': 'percentage of patients with aseptic consolidation at 6 months post-op'}], 'secondaryOutcomes': [{'measure': 'functional result of the procedure', 'timeFrame': 'up to 6 months', 'description': 'percentage of patients able to walk again at 6 months post-op'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Fractures']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.\n\nPatients will be asked to complete a questionnaire during follow-up consultations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent ankle surgery and have an ankle arthrodesis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\>18 years\n* having undergone septic nailing in the operating theatre\n* with social security coverage\n\nExclusion Criteria:\n\n* Patient with 6-month follow-up not possible (medical wandering, transient patient),\n* Patient who has benefited from another means of osteosynthesis\n* Patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery.\n* Persons able to give consent but unable to read or write French\n* Opposes participation in the study\n* Patients whose cognitive capacity does not allow them to answer questionnaires'}, 'identificationModule': {'nctId': 'NCT06338566', 'acronym': 'PROCLOU', 'briefTitle': 'Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Prospective Follow-up of Functional, Bone and Septic Results of Ankle Arthrodesis With Transplanted Nail', 'orgStudyIdInfo': {'id': '2021PPRC10'}, 'secondaryIdInfos': [{'id': '2023-A01975-40', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Follow-up', 'type': 'OTHER', 'description': 'Follow-up at D45, 3 months and 6 months, with scoring, radiological monitoring and assessment of wound healing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}