Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement

The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.

The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.

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Key information

Conditions

Hip Replacement Arthroplasty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ludwig-Maximilians-University Munich, Dept. of Dermatology, Munich, Bavaria, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

age over 18 years, necessity of hip replacement, informed consent

Exclusion criteria

acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

ARCUS-Sportklinik
DePuy Orthopaedics

Registry information

Official study title

Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2019
First posted: Jul 14, 2011
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.

Published trials that share one or more normalized conditions with this study.

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