Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
This trial is active, not recruiting.
|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|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Concentration of metal ions in the blood
time frame: preoperatively, and 3, 6, 12 and 24 months postoperatively.
Male or female participants from 25 years up to 65 years old.
Inclusion Criteria: - Hip osteoarthritis Exclusion Criteria: -
|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|
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