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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
  Purpose
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
Osteoarthritis Metal Ion Levels Device: Coated Total Knee Arthroplasty Device: Standard Total Knee Arthroplasty

Study Type: Interventional
Study Design: 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

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 ]

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

Enrollment: 120
Actual Study Start Date: March 2009
Study Completion Date: January 2017
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00862511


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00862511     History of Changes
Other Study ID Numbers: KneeIon
First Submitted: March 16, 2009
First Posted: March 17, 2009
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases