Overview

This trial is active, not recruiting.

Condition hip osteoarthritis
Treatment metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
Sponsor University Hospital, Ghent
Start date December 2003
End date August 2015
Trial size 120 participants
Trial identifier NCT00285974, 2003/398

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Concentration of metal ions in the blood
time frame: preoperatively, and 3, 6, 12 and 24 months postoperatively.

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

Inclusion Criteria: - Hip osteoarthritis Exclusion Criteria: -

Additional Information

Official title Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
Principal investigator Rene Verdonk, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.