Home >> HealthCenter >> ClinicalTrial

"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"

This study is currently recruiting participants.
Verified by Ullevaal University Hospital May 2007

Sponsored by:

Ullevaal University Hospital

Information provided by:

Ullevaal University Hospital

ClinicalTrials.gov Identifier:

NCT00473421

 

Purpose

Joint replacement is a well-documented and cost effective treatment of degenerative diseases in the hip (1,2). There are two different principles of fixation of prosthesis components; cemented and uncemented. The most common mode of fixation in Scandinavia has historically been with bone cement. In the recent years a reverse hybrid combination (uncemented stem and cemented cup) is gaining popularity, especially in Norway.

Beside luxation, infection and venous thromboembolism, the problem with aseptic loosening is a known complication. A marker for aseptic loosening is local bone loss around the components. This is measured with a densiometer and the method is Dual Energy X-ray Absorbtiometry (DXA). Periprosthetic bone loss is evaluated by series of DXA scans around the components over time. This enables us to follow changes in bone mineral density (BMD) close to the prosthesis.

We want to compare cemented and uncemented prostheses with this technique. This is a problem since we don’t know how much different contrast medias in bone cement affect DXA scans. This area is poorly investigated. Attempts have been made to exclude the cement-mantle from the measurements both digitally and manually, but these have showed poor precision. A kind of consensus of assuming that contrast medias in bone cement give an increase in measured BMD of 20% (4). This is used when comparing cemented and uncemented components.

We have preformed laboratory tests of different cements. Zirconium oxide (ZrO2) and Barium sulphate (BaSO4) are used as radiopacifiers. These contrast medias have different properties. Our test showed that Zirconium give 63% higher BMD when we scanned cement alone.

This is supported by a cadaver study showing significant differences between contrast free cement and ZrO2 /BaSO4 containing cements.

It is our opinion that it is necessary to perform a prospective study to investigate this more thoroughly.

The hypothesis of this study is that it is not accurate enough to add 20% in BMD for cemented implants when comparing them with uncemented implants. It is probably necessary to take into account the amount of cement used and kind of contrast medium.

Condition

Intervention

Phase

Primary and Secondary Osteoarthritis in Hip

 Procedure: Barium Sulphate and Zirconium Oxide

Phase I
Phase II

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Number of arms in study:  3

Further study details as provided by Ullevaal University Hospital:

Study start: May 2007

 

1234
Next

Home   |   About Us   |   Contact Us   |   Privacy   |   Terms Of Use   |   Advertise With Us   |   Sitemap
Copyright © 2022 Responsive Health
This site is intended to provide you with health information from publicly available sources, supporting vendors and partnered sources. While We make every effort to ensure that the information on this site is accurate, We make absolutely no assumption, inference, or declaration stating the information provided should be use as a source influencing any decisions on medical, diagnosis or treatment, or advice about what providers to use. The Site is an informational resource used for educational purposes only and cannot be used as a source used to make changes to medical treatment or lifestyle decisions without first consulting with your physician.