Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Technische Universität Dresden.
Recruitment status was  Active, not recruiting
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
  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: Total Knee Arthroplasty (TKA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypersensitivity against metal [ Time Frame: 1 y ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
allergy coated TKA
Device: Total Knee Arthroplasty (TKA)
Implantation of a TKA, either specially coated or normal
Active Comparator: 2
normal TKA
Device: Total Knee Arthroplasty (TKA)
Implantation of a TKA, either specially coated or normal

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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 desease complicating the participation in this study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Prof. K.-P.Günther, University Hospital Dresden, Orthopaedic Department
ClinicalTrials.gov Identifier: NCT00862511     History of Changes
Other Study ID Numbers: KneeIon 
Study First Received: March 16, 2009
Last Updated: August 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
metal ion concentration
total knee arthroplasty
metal hypersentivity

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 25, 2016