Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

Technische Universität Dresden120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Osteoarthritis Metal Ion Levels

Interventions

Coated Total Knee ArthroplastyDEVICE

Implantation of a coated Total Knee Arthroplasty

Standard Total Knee ArthroplastyDEVICE

Implantation of a Standard Total Knee Arthroplasty

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Dresden, Orthopaedic Department

Dresden, Germany

Outcomes

Primary Outcomes

Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)

Time frame: 1 y and 5y

Secondary Outcomes

Hypersensitivity against metal

Time frame: 1 y

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.