NCT01394744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

7.3 years

First QC Date

July 13, 2011

Last Update Submit

February 26, 2019

Conditions

Hip Replacement Arthroplasty

Keywords

metalioncytokinehip arthroplastybloodAssessmentcytokine profile

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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;

You may qualify if:

  • age over 18 years, necessity of hip replacement, informed consent

You may not qualify if:

  • acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ludwig-Maximilians-University Munich, Dept. of Dermatology

Munich, Bavaria, 80337, Germany

Location

ARCUS Sportklinik

Pforzheim, 75179, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum samples for metal ion and cytokine measurement; blood cells for cytokine-RNA assessment

Study Officials

  • Peter Thomas, Prof.

    Ludwig-Maximilans-University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2018

Study Completion

February 15, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

DE(2)