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Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862511
First Posted: March 17, 2009
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aesculap AG
Information provided by (Responsible Party):
Technische Universität Dresden
March 16, 2009
March 17, 2009
January 25, 2017
March 2009
December 2012   (Final data collection date for primary outcome measure)
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) [ Time Frame: 1 y and 5y ]
Same as current
Complete list of historical versions of study NCT00862511 on ClinicalTrials.gov Archive Site
Hypersensitivity against metal [ Time Frame: 1 y ]
Allergy against metal [ Time Frame: 5 y ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Osteoarthritis
  • Metal Ion Levels
  • Device: Coated Total Knee Arthroplasty
    Implantation of a coated Total Knee Arthroplasty
  • Device: Standard Total Knee Arthroplasty
    Implantation of a Standard Total Knee Arthroplasty
  • Experimental: Coated Total Knee Arthroplasty
    allergy coated TKA
    Intervention: Device: Coated Total Knee Arthroplasty
  • Active Comparator: Standard Total Knee Arthroplasty
    normal TKA
    Intervention: Device: Standard Total Knee Arthroplasty
Lützner J, Dinnebier G, Hartmann A, Günther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2017
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00862511
KneeIon
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Technische Universität Dresden
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
Technische Universität Dresden
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP