- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156598
Metal Ion Serum Concentrations in Patients With Total Hip Replacements
Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lorence Trick, MD, University of Texas Health Science Center Department of Orthopaedics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 045-0031-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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