Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

Not Applicable

Completed

• Conditions: Osteoarthritis; Metal Ion Levels

• Registration Number: NCT00862511
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2012-12
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)	1 y and 5y

Secondary Outcome Measures

Name	Time	Method
Hypersensitivity against metal	1 y

Trial Locations

Locations (1)

University Hospital Dresden, Orthopaedic Department; 🇩🇪 Dresden, Germany