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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
ARCUS-Sportklinik
DePuy Orthopaedics
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01394744
First received: July 13, 2011
Last updated: August 18, 2011
Last verified: May 2011
  Purpose

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
Total Hip Replacement

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Biospecimen Retention:   Samples Without DNA

Blood serum samples for metal ion and cytokine measurement; blood cells for cytokine-RNA assessment


Estimated Enrollment: 30
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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

total of 30 subjects; 10 with metal-on-metal, 10 with ceramic-on-ceramic and 10 with ceramic-on-metal hip replacement;

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394744

Locations
Germany
ARCUS Sportklinik Recruiting
Pforzheim, Germany, 75179
Contact: Christian Heisel, Prof.    0049-7231 ext 60556195    heisel@sportklinik.de   
Principal Investigator: Christian Heisel, Prof.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
ARCUS-Sportklinik
DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: Prof. Dr. Peter Thomas, Ludwig-Maximilians-University of Munich
ClinicalTrials.gov Identifier: NCT01394744     History of Changes
Other Study ID Numbers: 10-1739 / IIS2009029
Study First Received: July 13, 2011
Last Updated: August 18, 2011
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Keywords provided by Ludwig-Maximilians - University of Munich:
metal
ion
cytokine
hip arthroplasty
blood
Assessment
cytokine profile

ClinicalTrials.gov processed this record on September 18, 2014