Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)
Not Applicable
Completed
- Conditions
- OsteoarthritisMetal Ion Levels
- Interventions
- Device: Coated Total Knee ArthroplastyDevice: Standard Total Knee Arthroplasty
- Registration Number
- NCT00862511
- Lead Sponsor
- Technische Universität Dresden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coated Total Knee Arthroplasty Coated Total Knee Arthroplasty allergy coated TKA Standard Total Knee Arthroplasty Standard Total Knee Arthroplasty normal TKA
- Primary Outcome Measures
Name Time Method Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) 1 y and 5y
- Secondary Outcome Measures
Name Time Method Hypersensitivity against metal 1 y
Trial Locations
- Locations (1)
University Hospital Dresden, Orthopaedic Department
🇩🇪Dresden, Germany