This trial is active, not recruiting.

Condition hip replacement arthroplasty
Sponsor Ludwig-Maximilians - University of Munich
Collaborator ARCUS-Sportklinik
Start date August 2011
End date October 2016
Trial size 30 participants
Trial identifier NCT01394744, 10-1739 / IIS2009029


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Peter Thomas, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.