NCT00285974CompletedNot Applicable
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
University Hospital, Ghent2 sites in 1 country120 target enrollmentStarted: December 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Concentration of metal ions in the blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hip osteoarthritis
Exclusion Criteria
- Not provided
Arms & Interventions
hip prosthesis
Experimental
Intervention: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis (Device)
Outcomes
Primary Outcomes
Concentration of metal ions in the blood
Time Frame: preoperatively, and 3, 6, 12 and 24 months postoperatively.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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