Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT03473392
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2018-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
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': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial epidemiology', 'timeFrame': 'at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)', 'description': 'This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.'}], 'secondaryOutcomes': [{'measure': 'Treatment failure', 'timeFrame': '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': {'keywords': ['pre-treatment', 'antibiotherapy', 'prosthetic joint infection', 'treatment failure'], 'conditions': ['Exchange of Prosthetic Joint', 'Prosthetic Joint Infection', 'One-step Exchange']}, 'descriptionModule': {'briefSummary': 'The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..\n\nA puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.\n\nThe purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having had puncture which allowed to identify bacteria responsible for the IPA and having had a pre-treatment for a few days against those bacteria before a one-step exchange of prosthetic joint', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital\n* \\> 18 years old\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03473392', 'briefTitle': 'One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections', 'orgStudyIdInfo': {'id': '69HCL18_0237'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tristan FERRY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}