Risk Factors for Enhanced Inflammation to Arthroplasty Wear Particles: Analysis of Cytokine Production and Polymorphisms

Allergy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262065
• Other study ID #: 230-12
• Status: Completed
• Start date: July 2012
• Est. completion date: February 22, 2019

Study information

• Verified date: February 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: February 22, 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• arthroplasty

• over 18 years

• no infection

Exclusion Criteria:

• inability to consent

• malposition

• infection

Related Conditions & MeSH terms

• Allergy
• Implants
• Inflammation

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University Munich, Dept. of Dermatology	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Technische Universität München, University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymorphism frequency	Frequency of 4 different cytokine polymorphisms will be assessed in the 2 study groups.	2 years
Secondary	Cytokine production	Subgroup analysis: In vitro cytokine production of 20 patients with special polymorphism constellation will be analyzed after stimulation with particles.	1 year