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Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

NCT00862511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Coated Total Knee Arthroplasty

Implantation of a coated Total Knee Arthroplasty

DEVICE

Standard Total Knee Arthroplasty

Implantation of a Standard Total Knee Arthroplasty

Sponsors & Collaborators

  • Aesculap AG

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Jörg Lützner, MD · University Hospital Dresden, Orthopaedic Department

  • Stephan Kirschner, MD · University Hospital Dresden, Orthopaedic Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-12-31
Completion
2017-01-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862511 on ClinicalTrials.gov