Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01394744|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2011
Last Update Posted : September 5, 2017
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.
|Condition or disease|
|Hip Replacement Arthroplasty|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official 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|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||January 2018|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394744
|Ludwig-Maximilians-University Munich, Dept. of Dermatology|
|Munich, Bavaria, Germany, 80337|
|Pforzheim, Germany, 75179|
|Principal Investigator:||Peter Thomas, Prof.||Ludwig-Maximilans-University|