This trial is active, not recruiting.

Conditions allergy, implants
Sponsor Ludwig-Maximilians - University of Munich
Collaborator Technische Universität München
Start date July 2012
End date November 2016
Trial size 195 participants
Trial identifier NCT02262065, 230-12


Assessment of cytokine polymorphisms in 100 patients with aseptic complications to arthroplasty as compared to 100 symptom-free arthroplasty patients.

In selected patients additional in-vitro cytokine release assay with peripheral blood mononuclear cells (PBMC) stimulated with different wear particles.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Patients with suspected arthroplasty intolerance
Patients with well tolerated arthroplasties

Primary Outcomes

Polymorphism frequency
time frame: 2 years

Secondary Outcomes

Cytokine production
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - arthroplasty - over 18 years - no infection Exclusion Criteria: - inability to consent - malposition - infection

Additional Information

Official title Individual Risk Factors for Enhanced Inflammation to Arthroplasty Wear Particles: Analysis of Cytokine Polymorphisms and in Vitro Cytokine Production to Wear Particles (Ceramic, Metal, XPE)
Principal investigator Peter Thomas, Prof. Dr.
Description A cytokine polymorphism analysis in 100 individuals with aseptic implant intolerance reaction (patients of the implant allergy special ambulance) and in 100 asymptomatic patients with implanted endoprostheses will be done. Furthermore, supplementary clinical data (such as type of implant, hospital stay, discomfort), questionnaire-based history and a clinical score (WOMAC score) are recorded. In the subgroup analysis in 10 patients of implant patients with complaints with special found cytokine polymorphisms and 10 implant patients without problems the cytokine response to particles in vitro will assessed. 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.