Knee Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Outcome, Metal ion concentration, Results
Brief summary
Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.
Detailed description
Patients are randomized to receive a coated or uncoated TKA. Patients are assessed before surgery, after 3 month, 1 year and 5 years. Blood samples are collected in 7.5 ml S-Monovette® tubes (for trace metal analysis, Sarstedt AG, Germany) using a specific steel needle for trace metal analysis (Sarstedt AG, Germany). Within one hour, plasma was separated by centrifugation at 2500g for ten minutes. Samples were stored at -20°C before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer Z-8270 with Polarisation-Zeeman-Absorption (Hitachi Ltd., Japan). The accuracy and precision of the method is validated to \< 10% using the control materials SeronormTM Trace Elements Serum (SERO AS, Norway). The detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). All probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel. Clinical outcome is measured with the Knee Society Score, Oxford Knee Score, Short-Form 36 and University of Los Angeles Activity Score.
Interventions
Implantation of a coated Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty
Sponsors
Mathys Ltd Bettlach
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
Randomization to one of two implants
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* indication to TKA * no other metal implant
Exclusion criteria
* no informed consent * not able to understand study and/or questionnaires * Need of a higher constrained implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metal Ions (Cobalt, Chromium, Molydenum, Nickel) | before surgery, 1 year, 5 years | Change in Serum Metal Ion concentrations 1 and 5 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function | before surgery, 3 month, 1 year, 5 years | Knee Society Score |
| Patient Reported Outcome | before surgery, 3 month, 1 year, 5 years | Oxford Knee Score |
| Health-related Quality of Life | before surgery, 3 month, 1 year, 5 years | SF 36 |
| Activity | before surgery, 3 month, 1 year, 5 years | UCLA activity score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | through study completion, in average 5 years | Adverse Events |
Outcome results
None listed