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

Not Applicable

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Device: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis

• Registration Number: NCT00285974
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Hip osteoarthritis

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hip prosthesis	metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis	-

Primary Outcome Measures

Name	Time	Method
Concentration of metal ions in the blood	preoperatively, and 3, 6, 12 and 24 months postoperatively.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium