NCT00156598TerminatedNot Applicable
Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements
The University of Texas Health Science Center at San Antonio0 sites5 target enrollmentStarted: August 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 5
Study Overview
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:
- 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
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