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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2019-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

NCT00285974

Hip Osteoarthritis

COMPLETED NA

Metal Ions in Ceramic on Metal Total Hip Arthroplasty

NCT01437124

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis +1 more

COMPLETED

A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing

NCT00873444

Osteoarthritis Post-traumatic Arthritis Collagen Disorders +3 more

TERMINATED PHASE4

Metal on Metal Versus Ceramic on Metal Hip Replacement

NCT00208494

Non-inflammatory Joint Diseases

COMPLETED NA

Cytokine Profile and Metal Ion Concentrations at Patients Undergoing a Revision THR

NCT00289679

Hip Revision

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Replacement Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Thomas

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Thomas, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilans-University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ludwig-Maximilians-University Munich, Dept. of Dermatology

Munich, Bavaria, Germany

Site Status

ARCUS Sportklinik

Pforzheim, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-1739 / IIS2009029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pending Failure in Hard-hard Total Hip Arthroplasty

NCT02427984 COMPLETED

A Five-Year Metal-on-Metal Retrospective Clinical Study

NCT01481896 COMPLETED

Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

NCT01684631 COMPLETED

Metal Ion Serum Concentrations in Patients With Total Hip Replacements

NCT00156598 TERMINATED

Clinical, Radiographic and Laboratory Analysis of Failures of Joint Replacements

NCT01567696 UNKNOWN

Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting

NCT02061904 COMPLETED NA

Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty

NCT01246674 COMPLETED

RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

NCT00911599 COMPLETED NA

Outcomes Following Anterior Approach to Total Hip Arthroplasty

NCT01353885 TERMINATED

An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

NCT01134445 TERMINATED PHASE4

Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

NCT04748458 COMPLETED

Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

NCT00883805 WITHDRAWN

Metal-on-metal Hip Replacement MRI Study

NCT03409640 COMPLETED

Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

NCT04585022 TERMINATED NA

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

NCT07347821 RECRUITING

A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement

NCT00208390 TERMINATED PHASE4

EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

NCT04399928 COMPLETED

Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty

NCT06324708 RECRUITING NA

Immunology of Failing Metal-on-Metal Hip Replacement

NCT01517737 UNKNOWN

Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.

NCT07313449 RECRUITING

Cemented Acetabular Cups Clinical Study

NCT04831918 COMPLETED NA

Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

NCT03692364 UNKNOWN NA

A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

NCT00208455 TERMINATED PHASE4

Systemic Effects of Chronic Metal Ion Exposure From Metal-on Metal Hip Resurfacing

NCT01493141 COMPLETED

How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty

NCT06711042 COMPLETED