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Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

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. Identifier: NCT00862511
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : January 25, 2017
Aesculap AG
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Metal Ion Levels Device: Coated Total Knee Arthroplasty Device: Standard Total Knee Arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
Actual Study Start Date : March 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Coated Total Knee Arthroplasty
allergy coated TKA
Device: Coated Total Knee Arthroplasty
Implantation of a coated Total Knee Arthroplasty

Active Comparator: Standard Total Knee Arthroplasty
normal TKA
Device: Standard Total Knee Arthroplasty
Implantation of a Standard Total Knee Arthroplasty

Primary Outcome Measures :
  1. Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) [ Time Frame: 1 y and 5y ]

Secondary Outcome Measures :
  1. Hypersensitivity against metal [ Time Frame: 1 y ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 disease complicating the participation in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00862511

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University Hospital Dresden, Orthopaedic Department
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Aesculap AG
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Principal Investigator: Jörg Lützner, MD University Hospital Dresden, Orthopaedic Department
Principal Investigator: Stephan Kirschner, MD University Hospital Dresden, Orthopaedic Department
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden Identifier: NCT00862511    
Other Study ID Numbers: KneeIon
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technische Universität Dresden:
metal ion concentration
total knee arthroplasty
metal hypersensitivity
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases