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Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aesculap AG
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00862511
First received: March 16, 2009
Last updated: August 10, 2012
Last verified: August 2012

March 16, 2009
August 10, 2012
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00862511 on ClinicalTrials.gov Archive Site
Hypersensitivity against metal [ Time Frame: 1 y ] [ Designated as safety issue: No ]
Allergy against metal [ Time Frame: 5 y ] [ Designated as safety issue: No ]
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: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Metal Ion Levels
Device: Total Knee Arthroplasty (TKA)
Implantation of a TKA, either specially coated or normal
  • Experimental: 1
    allergy coated TKA
    Intervention: Device: Total Knee Arthroplasty (TKA)
  • Active Comparator: 2
    normal TKA
    Intervention: Device: Total Knee Arthroplasty (TKA)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2015
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 desease complicating the participation in this study
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00862511
KneeIon
No
Prof. K.-P.Günther, University Hospital Dresden, Orthopaedic Department
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
August 2012

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