An interventional study of Coated Total Knee Arthroplasty and Standard Total Knee Arthroplasty in Knee Osteoarthritis, sponsored by Technische Universität Dresden. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment
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.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of a coated Total Knee Arthroplasty
Device: Coated Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty
Device: Standard Total Knee Arthroplasty
Implantation of a coated Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty
Metal Ions (Cobalt, Chromium, Molydenum, Nickel)
Change in Serum Metal Ion concentrations 1 and 5 years after surgery
Time frame: before surgery, 1 year, 5 years
Function
Knee Society Score
Time frame: before surgery, 3 month, 1 year, 5 years
Patient Reported Outcome
Oxford Knee Score
Time frame: before surgery, 3 month, 1 year, 5 years
Health-related Quality of Life
SF 36
Time frame: before surgery, 3 month, 1 year, 5 years
Activity
UCLA activity score
Time frame: before surgery, 3 month, 1 year, 5 years
Adverse Events
Adverse Events
Time frame: through study completion, in average 5 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Technische Universität Dresden