Metal Ion Serum Concentrations in Patients With Total Hip Replacements

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT00156598
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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.

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:

1. people with 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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified