Metal Ion Serum Concentrations in Patients With Total Hip Replacements

NCT ID: NCT00156598

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2010-05-31

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.

Conditions

Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorence Trick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center Department of Orthopaedics

Other Identifiers

045-0031-006

Identifier Type: -

Identifier Source: org_study_id