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

Hip Replacement Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394744
• Other study ID #: 10-1739 / IIS2009029
• Status: Completed
• Start date: August 2011
• Est. completion date: February 15, 2019

Study information

• Verified date: February 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 15, 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Replacement Arthroplasty

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University Munich, Dept. of Dermatology	Munich	Bavaria
Germany	ARCUS Sportklinik	Pforzheim

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	ARCUS-Sportklinik, DePuy Orthopaedics

Country where clinical trial is conducted

Germany,