Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 3:20 PM
Study NCT ID:
NCT03164733
Status:
UNKNOWN
Last Update Posted:
2017-05-24
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Age Dependency of Biological Reaction on Wear Particles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055256', 'term': 'Infectious Disease Incubation Period'}], 'ancestors': [{'id': 'D018562', 'term': 'Disease Transmission, Infectious'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples of patients that have received a total hip arthroplasty'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biological reaction', 'timeFrame': 'one hour', 'description': 'TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty', 'Wear']}, 'descriptionModule': {'briefSummary': 'Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (\\<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.\n\nThe main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '80 patients having received a total hip arthroplasty 4 weeks before blood sample for this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having received a total hip arthroplasty 4 weeks before blood sample for this study\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT03164733', 'briefTitle': 'Age Dependency of Biological Reaction on Wear Particles', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Age Dependency of Biological Reaction on Wear Particles', 'orgStudyIdInfo': {'id': 'AgeWear'}}, 'armsInterventionsModule': {'armGroups': [{'label': '<40', 'description': 'patients younger than 40 years', 'interventionNames': ['Other: incubation']}, {'label': '40-60', 'description': 'patients younger than 60 years and not older than 40 years', 'interventionNames': ['Other: incubation']}, {'label': '60-80', 'description': 'patients younger than 80 years and not older than 80 years', 'interventionNames': ['Other: incubation']}, {'label': '>80', 'description': 'patients older than 80 years', 'interventionNames': ['Other: incubation']}], 'interventions': [{'name': 'incubation', 'type': 'OTHER', 'description': 'standardized wear particles are co-incubated with isolated patient cells (monocytes)', 'armGroupLabels': ['40-60', '60-80', '<40', '>80']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Georg Matziolis, MD PhD', 'role': 'CONTACT', 'email': 'g.matziolis@krankenhaus-eisenberg.de', 'phone': '+49 36691 81011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of the orthopaedic department', 'investigatorFullName': 'Georg Matziolis', 'investigatorAffiliation': 'Jena University Hospital'}}}}