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Completed

NCT Number: NCT02262065

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

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ludwig-Maximilians-University Munich, Dept. of Dermatology

Munich, Bavaria, 80337, Germany

About this study

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:

  • 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.

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • arthroplasty
  • over 18 years
  • no infection

Exclusion criteria

  • inability to consent
  • malposition
  • infection

Treatment and study plan

Primary outcomes

  1. Polymorphism frequency

    Time frame: 2 years

    Frequency of 4 different cytokine polymorphisms will be assessed in the 2 study groups.

Secondary outcomes

  1. Cytokine production

    Time frame: 1 year

    Subgroup analysis: In vitro cytokine production of 20 patients with special polymorphism constellation will be analyzed after stimulation with particles.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Technical University of Munich
  • University of Rostock

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Oct 10, 2014
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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