Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

Technische Universität Dresden

Status: Completed

Conditions: Osteoarthritis; Metal Ion Levels

Treatments: Device: Standard Total Knee Arthroplasty; Device: Coated Total Knee Arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00862511

KneeIon

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Coated Total Knee Arthroplasty

Experimental group

Description:

allergy coated TKA

Treatment:

Device: Coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Active Comparator group

Description:

normal TKA

Treatment:

Device: Standard Total Knee Arthroplasty