Allergy Clinical Trial - Risk Factors for Enhanced Inflammation to

Status Completed

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02262065
Study type	Observational
Source	Ludwig-Maximilians - University of Munich
Contact
Status	Completed
Phase
Start date	July 2012
Completion date	February 22, 2019

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02032056` - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period	N/A
Completed	`NCT01842711` - Cumulative Irritation Patch Test	N/A
Completed	`NCT01633840` - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges	N/A
Completed	`NCT00997971` - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein	Phase 3
Completed	`NCT00554983` - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1	Phase 3
Completed	`NCT00331929` - Respiratory Health Study of Children in Kiryat Tivon	N/A
Completed	`NCT00220753` - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy	N/A
Completed	`NCT00232518` - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis	N/A
Completed	`NCT04126096` - Negative Predictive Value and NIC of Beta-Lactam Antibiotics.	N/A
Completed	`NCT04046731` - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation	N/A
Completed	`NCT04004351` - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Not yet recruiting	`NCT04071821` - Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg	Phase 1
Completed	`NCT04418999` - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus	Early Phase 1
Completed	`NCT04186949` - Early Origins of Allergy and Asthma
Completed	`NCT02127801` - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants	Phase 1
Enrolling by invitation	`NCT05011071` - The Alberta BLOOM Premature Child Study
Not yet recruiting	`NCT06330974` - Allergy, Asthma, and Atopic Eczema in Finland
Terminated	`NCT02601690` - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Completed	`NCT02596321` - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms