Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
Recruitment status was Recruiting
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.
Total Hip Replacement
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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|
Blood serum samples for metal ion and cytokine measurement; blood cells for cytokine-RNA assessment
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394744
|Pforzheim, Germany, 75179|
|Contact: Christian Heisel, Prof. 0049-7231 ext 60556195 firstname.lastname@example.org|
|Principal Investigator: Christian Heisel, Prof.|