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NCT00285974 Clinical Trial

Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

Hip Osteoarthritis Clinical Trial

Official title:
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285974
Other study ID # 2003/398
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2003
Est. completion date November 2005

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: - Hip osteoarthritis Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of metal ions in the blood preoperatively, and 3, 6, 12 and 24 months postoperatively.
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