NCT00862511

Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Metal Ion Levels

Interventions

Type	Name	Description
DEVICE	Coated Total Knee Arthroplasty	Implantation of a coated Total Knee Arthroplasty
DEVICE	Standard Total Knee Arthroplasty	Implantation of a Standard Total Knee Arthroplasty

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-12-01
• Completion: 2017-01-01
• First posted: 2009-03-17
• Last updated: 2017-01-25

Locations

1 site across 1 country: Germany