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Metal Ion Serum Concentrations in Patients With Total Hip Replacements

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ClinicalTrials.gov Identifier: NCT00156598
Recruitment Status : Terminated (Resident graduated; faculty mentor retired)
First Posted : September 12, 2005
Last Update Posted : July 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Osteoarthritis

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 Design

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements
Study Start Date : August 2004
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Local surgeon's patients who have had a hip implant.
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
  • other types of metal implants or dental prostheses
  • rheumatoid arthritis
  • hip infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156598


Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
DePuy Orthopaedics
Investigators
Principal Investigator: Lorence Trick, MD University of Texas Health Science Center Department of Orthopaedics
More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00156598     History of Changes
Other Study ID Numbers: 045-0031-006
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
metal ion concentration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases