Risk Factors for Enhanced Inflammation to Arthroplasty Wear Particles: Analysis of Cytokine Production and Polymorphisms
NCT ID: NCT02262065
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
195 participants
OBSERVATIONAL
2012-07-31
2019-02-22
Brief Summary
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In selected patients additional in-vitro cytokine release assay with peripheral blood mononuclear cells (PBMC) stimulated with different wear particles.
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Detailed Description
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Test parameters:
1. total collective:
the DNA of cryopreserved blood sample will be isolated. By polymerase chain reaction, four different known polymorphisms will be analyzed, three IL-1B genes (IL-1B-3954 IL-1B-31, and IL-1B-511), and a IL-1ß receptor antagonist gene (IL -1-RN, intron 2 VNTR). Molecular analysis includes DNA isolation, polymerase chain reactions (PCR) and gel electrophoresis.
2. Subgroup analysis:
Peripheral blood cells will be isolated from 10 implant patients with complications and 10 symptom-free persons and stimulated in cell culture with control stimuli, the IL-1ß-inducer lipopolysaccharide (LPS) and ceramic particles (BIOLOX delta)\*, CoCrMo particles and XPE-particles\*\* cultured separately or in combination. The secretion of IL-1ß and selected proinflammatory cytokines will be measured. The methods include cell isolation by density centrifugation and analysis of cell culture supernatants by a multiplex cytokine measurement assay by flow cytometry.
\* Supplied CeramTec
\*\* Generated and processed by the Working Group of the cooperation partner Prof. R. Bader (University Hospital Rostock) in special carrier system for cell culture stimulation approach
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients
Patients with suspected arthroplasty intolerance
No interventions assigned to this group
Controls
Patients with well tolerated arthroplasties
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* over 18 years
* no infection
Exclusion Criteria
* malposition
* infection
18 Years
ALL
Yes
Sponsors
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Technical University of Munich
OTHER
University of Rostock
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Peter Thomas
Prof. Dr.
Principal Investigators
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Peter Thomas, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ludwig-Maximilians - University of Munich
Locations
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Ludwig-Maximilians-University Munich, Dept. of Dermatology
Munich, Bavaria, Germany
Countries
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Other Identifiers
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230-12
Identifier Type: -
Identifier Source: org_study_id
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