Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-03-05 @ 12:57 PM
Study NCT ID:
NCT02853461
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2016-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013010', 'term': 'Sonication'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative analysis of sonication fluid after sonication of explanted bearing components of the hip endoprosthesis during a revision surgery', 'timeFrame': 'Prospective: patient recruitment up to 2 years', 'description': 'Qualitative Analysis, i.e. frequency of positive sonication fluid cultures (No. positive/No. all cultures) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene), the number of variables which will be evaluated following: bearing component and its material (Ceramic, Cobalt-chrome-metal, and Polyethylene).\n\nAll three material types will be compared between each other regard to microbiology analysis of sonication fluid of bearing components.'}, {'measure': 'Quantitative Analysis e.g. No. of microorganisms in sonication fluid (CFU/ml) deriving from 3 different biomaterials (namely: Ceramic, Cobalt-chrome-metal, and Polyethylene).', 'timeFrame': 'Prospective: patient recruitment up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Amount of patients with septic loosening of hip joint', 'timeFrame': 'Prospective: patient recruitment up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['biofilm', 'periprosthetic joint infection', 'hip', 'endoprothesis', 'ceramic', 'bearing components', 'sonication', 'low grade infection', 'joint aspiration'], 'conditions': ['Sonication', 'Total Hip Replacement', 'Biofilm']}, 'referencesModule': {'references': [{'pmid': '20164283', 'type': 'BACKGROUND', 'citation': 'Achermann Y, Vogt M, Leunig M, Wust J, Trampuz A. Improved diagnosis of periprosthetic joint infection by multiplex PCR of sonication fluid from removed implants. J Clin Microbiol. 2010 Apr;48(4):1208-14. doi: 10.1128/JCM.00006-10. Epub 2010 Feb 17.'}, {'pmid': '24692617', 'type': 'BACKGROUND', 'citation': 'Banche G, Allizond V, Bracco P, Bistolfi A, Boffano M, Cimino A, Brach del Prever EM, Cuffini AM. Interplay between surface properties of standard, vitamin E blended and oxidised ultra high molecular weight polyethylene used in total joint replacement and adhesion of Staphylococcus aureus and Escherichia coli. Bone Joint J. 2014 Apr;96-B(4):497-501. doi: 10.1302/0301-620X.96B4.32895.'}, {'pmid': '22467526', 'type': 'BACKGROUND', 'citation': 'Gomez-Barrena E, Esteban J, Medel F, Molina-Manso D, Ortiz-Perez A, Cordero-Ampuero J, Puertolas JA. Bacterial adherence to separated modular components in joint prosthesis: a clinical study. J Orthop Res. 2012 Oct;30(10):1634-9. doi: 10.1002/jor.22114. Epub 2012 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). The hip prosthesis bearing components are composed from different material. The purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.', 'detailedDescription': 'The main reasons for hip prosthesis failure are aseptic loosening and periprosthetic joint infection (PJI). The real frequency of PJI is probably largely underestimated because of non-standardized definition criteria, diagnostic procedure, treatment algorithm and other confounders. Therefore, data from joint registries are not reflecting the frequency of PJI and can be misleading; particularly low-grade PJI can be frequently misdiagnosed as aseptic failure.\n\nMicrobiological analysis of sonicate has in comparison with joint aspirate significantly higher sensitivity and specificity, which allows better detection of low grade infection. With aspiration only free-floating, high metabolically active, planktonic form of bacteria could be collected. Contrarily, the less metabolically active bacteria are hidden under the biofilm can remain undetected.\n\nSonication of prosthetic material mechanically dislodge the biofilm from surface and expose the sessile bacteria for the microbiological analysis.\n\nAll foreign materials provoke biofilm formation however, different materials showed different resistance for biofilm adhesion.\n\nIn this study patients with PJI are undergoing standard one- or two- stage revision procedure of the hip. The removed bearing components will be sonicated and sent in microbiological analysis. The ceramic, metal and polyethylene prosthesis components will undergo qualitative and quantitative microbiological analysis. The materials will be compared regarding to the presence of biofilm formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥18 y, undergoing hip prosthesis explantation for infection or mechanical (aseptic) reason.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be aged 18 or more.\n* Subject must be scheduled to undergo an explanation of the hip endoprosthesis during the 1- or 2- stage revision procedure because of the septic or mechanical indication.\n* Subject must personally sign and date the informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Patient not scheduled for the index Operation procedure with removal of hip endoprosthesis'}, 'identificationModule': {'nctId': 'NCT02853461', 'briefTitle': 'Biofilm Investigation on Bearing Components of Explanted Hip Joint Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Biofilm Investigation on Ceramic, Metal and Polyethylene Bearing Components From Explanted Hip Joint Prosthesis', 'orgStudyIdInfo': {'id': 'Endo 015/15'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sonication', 'type': 'OTHER', 'description': 'Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.'}, {'name': 'Microbiological analysis', 'type': 'OTHER', 'description': 'Plating the sonicates on agar plates.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andrej Trampuz, MD', 'role': 'CONTACT', 'email': 'andrej.trampuz@charite.de', 'phone': '+49 30 450 615 073'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Andrej Trampuz, MD', 'role': 'CONTACT', 'email': 'andrej.trampuz@charite.de', 'phone': '+49 30 450 615 073'}], 'overallOfficials': [{'name': 'Andrej Trampuz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ceram Tec GmbH', 'class': 'UNKNOWN'}, {'name': 'Pro-Implant Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrej Trampuz', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}