Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

This study is ongoing, but not recruiting participants.
Aesculap AG
Information provided by:
Technische Universität Dresden Identifier:
First received: March 16, 2009
Last updated: August 10, 2012
Last verified: August 2012

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.

Condition Intervention
Metal Ion Levels
Device: Total Knee Arthroplasty (TKA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

Resource links provided by NLM:

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) [ Time Frame: 1 y and 5y ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypersensitivity against metal [ Time Frame: 1 y ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
allergy coated TKA
Device: Total Knee Arthroplasty (TKA)
Implantation of a TKA, either specially coated or normal
Active Comparator: 2
normal TKA
Device: Total Knee Arthroplasty (TKA)
Implantation of a TKA, either specially coated or normal


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 desease complicating the participation in this study
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Please refer to this study by its identifier: NCT00862511

University Hospital Dresden, Orthopaedic Department
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Aesculap AG
Principal Investigator: Jörg Lützner, MD University Hospital Dresden, Orthopaedic Department
Principal Investigator: Stephan Kirschner, MD University Hospital Dresden, Orthopaedic Department
  More Information

No publications provided by Technische Universität Dresden

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. K.-P.Günther, University Hospital Dresden, Orthopaedic Department Identifier: NCT00862511     History of Changes
Other Study ID Numbers: KneeIon
Study First Received: March 16, 2009
Last Updated: August 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
metal ion concentration
total knee arthroplasty
metal hypersentivity processed this record on October 09, 2015