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Completed

NCT Number: NCT00862511

Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Metal Ion Levels Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coated Total Knee Arthroplasty

Device

Implantation of a coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Device

Implantation of a Standard Total Knee Arthroplasty

Primary outcomes

  1. Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)

    Time frame: 1 y and 5y

Secondary outcomes

  1. Hypersensitivity against metal

    Time frame: 1 y

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Aesculap AG

Registry information

Official study title

A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

Important dates

Study start
2009
Primary completion
2012
Study completion
2017
First posted
Mar 17, 2009
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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