Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 6:40 PM
Study NCT ID:
NCT06448260
Status:
COMPLETED
Last Update Posted:
2025-04-16
First Post:
2024-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2024-06-01', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The possibility of walking without a prosthesis', 'timeFrame': 'Immediatly after inclusion', 'description': 'Yes / No'}, {'measure': 'Walking perimeter with prosthesis', 'timeFrame': 'Immediatly after inclusion', 'description': 'In meters'}, {'measure': 'Number of re-amputation since first amputation', 'timeFrame': 'Immediatly after inclusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amputation', 'Prothesis', 'Outcome'], 'conditions': ['Amputation, Surgical', 'Walking, Difficulty']}, 'referencesModule': {'references': [{'pmid': '29320640', 'type': 'BACKGROUND', 'citation': 'Braaksma R, Dijkstra PU, Geertzen JHB. Syme Amputation: A Systematic Review. Foot Ankle Int. 2018 Mar;39(3):284-291. doi: 10.1177/1071100717745313. Epub 2018 Jan 10.'}, {'pmid': '28288686', 'type': 'BACKGROUND', 'citation': 'Dillon MP, Quigley M, Fatone S. Outcomes of dysvascular partial foot amputation and how these compare to transtibial amputation: a systematic review for the development of shared decision-making resources. Syst Rev. 2017 Mar 14;6(1):54. doi: 10.1186/s13643-017-0433-7.'}, {'pmid': '36897730', 'type': 'BACKGROUND', 'citation': 'van der Wal GE, Dijkstra PU, Geertzen JHB. Lisfranc and Chopart amputation: A systematic review. Medicine (Baltimore). 2023 Mar 10;102(10):e33188. doi: 10.1097/MD.0000000000033188.'}, {'pmid': '30612550', 'type': 'BACKGROUND', 'citation': 'Spoden M, Nimptsch U, Mansky T. Amputation rates of the lower limb by amputation level - observational study using German national hospital discharge data from 2005 to 2015. BMC Health Serv Res. 2019 Jan 6;19(1):8. doi: 10.1186/s12913-018-3759-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient treated at the institut Rober Merle d'Aubigné", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Syme or Pirogoff or ATCT or arthrodesized Chopart type amputation\n* Age \\> 18 years old,\n* First fitting or renewal of Syme type prosthesis delivered to IRMA between January 2008 and December 2018\n\nExclusion Criteria:\n\n* Refusal documented in the file that the data be used for scientific purposes,\n* Congenital etiology of the condition.'}, 'identificationModule': {'nctId': 'NCT06448260', 'acronym': 'DEVSYME', 'briefTitle': 'Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support', 'organization': {'class': 'OTHER', 'fullName': "Institut Robert Merle d'aubigné"}, 'officialTitle': 'Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support', 'orgStudyIdInfo': {'id': '2024-A00393-44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with ATCT', 'description': 'Patient with tibiocalcaneal arthrodesis with talectomy amputation', 'interventionNames': ['Other: Questionnary']}], 'interventions': [{'name': 'Questionnary', 'type': 'OTHER', 'description': 'Data from theses patients will be collected in our personnal data base with ask of consent according to the law Then each patient alive will have questionnary to answer by phone or during a visit.', 'armGroupLabels': ['Patient with ATCT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valenton', 'country': 'France', 'facility': "Institut Robert Merle d'Aubigné", 'geoPoint': {'lat': 48.74527, 'lon': 2.46467}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Robert Merle d'aubigné", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}