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

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ClinicalTrials.gov Identifier: NCT01394744
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
ARCUS-Sportklinik
DePuy Orthopaedics
Information provided by (Responsible Party):
Peter Thomas, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date July 13, 2011
First Posted Date July 14, 2011
Last Update Posted Date February 27, 2019
Study Start Date August 2011
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01394744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
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
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood serum samples for metal ion and cytokine measurement; blood cells for cytokine-RNA assessment
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;
Condition Hip Replacement Arthroplasty
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July¬†13,¬†2011)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date February 15, 2019
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01394744
Other Study ID Numbers 10-1739 / IIS2009029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Thomas, Ludwig-Maximilians - University of Munich
Study Sponsor Ludwig-Maximilians - University of Munich
Collaborators
  • ARCUS-Sportklinik
  • DePuy Orthopaedics
Investigators
Principal Investigator: Peter Thomas, Prof. Ludwig-Maximilans-University
PRS Account Ludwig-Maximilians - University of Munich
Verification Date February 2019