Clinical Trial: Metal Ion Serum Concentrations in Patients with Metal-on-Metal Vs. Metal on Polyethylene Total Hip Replacements

This study is currently recruiting patients.
Verified by The University of Texas Health Science Center at San Antonio September 2005

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

It has been 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 those with a plastic and metal prosthesis. To find out if this is true, we will be drawing blood samples and comparing the values from 3 groups of people. We want to test people with 1. metal on metal hip replacements, 2. loosening of a plastic and metal prosthesis and 3. evidence of osteoarthritis and are awaiting a total hip replacement.
Condition
Osteoarthritis

MedlinePlus related topics:  Osteoarthritis

Study Type: Observational
Study Design: Natural History, Cross-Sectional, Convenience Sample, Retrospective/Prospective Study

Official Title: Cobalt, Chromium and Titanium Serum Concentrations in Total Hip Replacement Patients

Further Study Details: 

Expected Total Enrollment:  45

Study start: August 2004;  Expected completion: December 2005
Last follow-up: June 2005;  Data entry closure: December 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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 no other types of metal implants or dental prostheses. rheumatoid arthritis hip infection

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Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00156598

Kathy Kinnaman, RN      2105670204    kinnaman@uthscsa.edu

Texas
      University Physicians Group Diagnostic Pavillion, San Antonio,  Texas,  78229,  United States; Recruiting
Kathy Nelson  210-592-0180 
Doug Clouse, MD,  Sub-Investigator

Study chairs or principal investigators

Lorence Trick, MD,  Principal Investigator,  University of Texas Health Science Center Department of Orthopaedics   

More Information

Study ID Numbers:  045-0031-006
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00156598
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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