Metal Ion Serum Concentrations in Patients With Total Hip Replacements

This study has been terminated.
(Resident graduated; faculty mentor retired)
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00156598
First received: September 7, 2005
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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
Osteoarthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 5
Study Start Date: August 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 7, 2005
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 09, 2014