Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT04371068
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2020-04-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of bacteria isolated isolated', 'timeFrame': 'every day until 15 days of culture', 'description': 'type of bacteria isolated'}], 'secondaryOutcomes': [{'measure': 'time to positivity of cultures', 'timeFrame': 'every day until 15 days of culture', 'description': 'time to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone and joint infection', 'biofilm', 'joint arthroplasty', 'implant failure', 'prosthetic joint infection', 'dithiothreitol'], 'conditions': ['Chronic PJIs']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.crioac-lyon.fr', 'label': 'website of CRIOAc Lyon'}]}, 'descriptionModule': {'briefSummary': 'Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.\n\nIn this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.', 'detailedDescription': 'Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.\n\nIn this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with painful prosthesis or prosthesis loosening \\<10 years treated at the CRIOAc Lyon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients with painful prosthesis or prosthesis loosening \\<10 years\n\n* without mechanical explanation,\n* without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),\n* without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).\n\nExclusion Criteria:\n\nPatients with painful prosthesis or prosthesis loosening\n\n* with mechanical explanation,\n* or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),\n* with a previous microbiological diagnosis'}, 'identificationModule': {'nctId': 'NCT04371068', 'briefTitle': 'Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic', 'orgStudyIdInfo': {'id': '18-265'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients suspected of low-grade PJIs', 'description': 'Adult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria', 'interventionNames': ['Biological: Culture of removed prosthesis using DTT']}], 'interventions': [{'name': 'Culture of removed prosthesis using DTT', 'type': 'BIOLOGICAL', 'description': 'No specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT).', 'armGroupLabels': ['Patients suspected of low-grade PJIs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'FREDERIC LAURENT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LAURENT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical research assistant', 'investigatorFullName': 'Eugénie MABRUT', 'investigatorAffiliation': 'Hospices Civils de Lyon'}}}}