Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156598
Status:
TERMINATED
Last Update Posted:
2012-07-02
First Post:
2005-09-07
Brief Title:
Metal Ion Serum Concentrations in Patients With Total Hip Replacements
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Cobalt Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs Metal on Polyethylene Total Hip Replacements
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Resident graduated faculty mentor retired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None