Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)
This trial is active, not recruiting.
|Conditions||osteoarthritis, metal ion levels|
|Treatment||total knee arthroplasty (tka)|
|Sponsor||Technische Universität Dresden|
|Start date||March 2009|
|End date||December 2012|
|Trial size||120 participants|
|Trial identifier||NCT00862511, KneeIon|
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.
|Intervention model||parallel assignment|
allergy coated TKA
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
time frame: 1 y and 5y
Hypersensitivity against metal
time frame: 1 y
Male or female participants of any age.
Inclusion Criteria: - Indication for TKA in primary oder secondary osteoarthritis of the knee - Patient's consent Exclusion Criteria: - Additional Implants present - Allergy against constituents of implant or cement - Any malignancies - Renal insufficiency - Any additional serious desease complicating the participation in this study
|Official title||A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses|
|Principal investigator||Jörg Lützner, MD|
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