Metal Ion Levels, Osteoarthritis
Conditions
Keywords
metal ion concentration, total knee arthroplasty, metal hypersensitivity
Brief summary
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.
Interventions
Implantation of a coated Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty
Sponsors
Aesculap AG
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 disease complicating the participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) | 1 y and 5y |
Secondary
| Measure | Time frame |
|---|---|
| Hypersensitivity against metal | 1 y |
Countries
Germany
Outcome results
None listed