Metal Ion Serum Concentrations in Patients With Total Hip Replacements

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center at San Antonio, June 2007

First Received: September 7, 2005 Last Updated: June 14, 2007 History of Changes

Sponsors and Collaborators:	The University of Texas Health Science Center at San Antonio DePuy Orthopaedics
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00156598

Purpose

Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.

Condition
Osteoarthritis

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Convenience Sample, Retrospective/Prospective Study
Official Title:	Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Estimated Enrollment:	45
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2007

Detailed Description:

It is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. To find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people:

people with metal on metal hip replacements
loosening of a plastic and metal prosthesis and
evidence of osteoarthritis and are awaiting a total hip replacement.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning.

Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement

Exclusion Criteria:

renal dysfunction
other types of metal implants or dental prostheses
rheumatoid arthritis
hip infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156598

Contacts

Contact: Pat Cathcart

(210) 567-0204

cathcart@uthscsa.edu

Locations

United States, Texas
UT Medicine- San Antonio (formerly UPG-DP clinic)	Recruiting
San Antonio, Texas, United States, 78229
Contact: Kathy Nelson 210-592-0180
Sub-Investigator: Hussein Turki, MD

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

DePuy Orthopaedics

Investigators

Principal Investigator:

Lorence Trick, MD

University of Texas Health Science Center Department of Orthopaedics

More Information

No publications provided

Study ID Numbers:	045-0031-006
Study First Received:	September 7, 2005
Last Updated:	June 14, 2007
ClinicalTrials.gov Identifier:	NCT00156598 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:

metal ion concentration

Study placed in the following topic categories:

Chromium
Musculoskeletal Diseases
Osteoarthritis
Cobalt

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009