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

NCT01394744 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

  • Hip Replacement Arthroplasty

Sponsors & Collaborators

  • ARCUS-Sportklinik

    collaborator UNKNOWN

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Peter Thomas, Prof. · Ludwig-Maximilans-University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2018-11-30
Completion
2019-02-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394744 on ClinicalTrials.gov