Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis Metal Ion Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coated Total Knee Arthroplasty

allergy coated TKA

Group Type EXPERIMENTAL

Coated Total Knee Arthroplasty

Intervention Type DEVICE

Implantation of a coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

normal TKA

Group Type ACTIVE_COMPARATOR

Standard Total Knee Arthroplasty

Intervention Type DEVICE

Implantation of a Standard Total Knee Arthroplasty

Interventions

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Coated Total Knee Arthroplasty

Implantation of a coated Total Knee Arthroplasty

Intervention Type DEVICE

Standard Total Knee Arthroplasty

Implantation of a Standard Total Knee Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No