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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Hip Replacement Arthroplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01394744

10-1739 / IIS2009029

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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