Overview

This trial is active, not recruiting.

Conditions osteoarthritis, metal ion levels
Treatment total knee arthroplasty (tka)
Sponsor Technische Universität Dresden
Collaborator Aesculap AG
Start date March 2009
End date December 2012
Trial size 120 participants
Trial identifier NCT00862511, KneeIon

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
allergy coated TKA
total knee arthroplasty (tka)
Implantation of a TKA, either specially coated or normal
(Active Comparator)
normal TKA
total knee arthroplasty (tka)
Implantation of a TKA, either specially coated or normal

Primary Outcomes

Measure
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
time frame: 1 y and 5y

Secondary Outcomes

Measure
Hypersensitivity against metal
time frame: 1 y

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
Principal investigator Jörg Lützner, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Technische Universität Dresden.