Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-25 @ 2:36 AM
Study NCT ID:
NCT03620305
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'Description of treatment of septic pseudarthrosis : chirurgical treatment'}], 'secondaryOutcomes': [{'measure': 'Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'Description of treatment of septic pseudarthrosis : medical treatment'}, {'measure': 'Treatment failure : rate of failure with this 2 times chirurgical treatment', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pseudoarthrosis of Bone']}, 'descriptionModule': {'briefSummary': 'Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': ': patients having septic pseudarthrosis managed with 2 steps chirurgical treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03620305', 'briefTitle': 'Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center', 'orgStudyIdInfo': {'id': '18-078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Description of treatment of septic pseudarthrosis', 'description': 'chirurgical and medical treatment', 'interventionNames': ['Other: Description of treatment of septic pseudarthrosis']}], 'interventions': [{'name': 'Description of treatment of septic pseudarthrosis', 'type': 'OTHER', 'description': 'description of chirurgical 2 steps management of septic pseudarthrosis', 'armGroupLabels': ['Description of treatment of septic pseudarthrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Tristan Ferry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon - Hôpital Croix-Rousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CRA', 'investigatorFullName': 'Eugénie MABRUT', 'investigatorAffiliation': 'Hospices Civils de Lyon'}}}}