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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Ullevaal University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473421
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ullevaal University Hospital
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Study Start Date: May 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Osteoarthritis

Exclusion Criteria:

  • more than 80 yrs
  • systemic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473421


Contacts
Contact: Jon Dahl +4791848655 jon.dahl@mac.com
Contact: Lars Nordsletten +4791721568 lars.nordsletten@medisin.uio.no

Locations
Norway
Ullevaal university hospital Recruiting
Oslo, Norway, 0407
Contact: Jon Dahl, MD    91848655    jon.dahl@mac.com   
Contact: Jon Dahl    91848655    jon.dahl@mac.com   
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Lars Nordsletten, MD Ph.D Ullevaal University Hospital
Principal Investigator: Jon Dahl, MD Ullevaal Univerity hospital
  More Information

ClinicalTrials.gov Identifier: NCT00473421     History of Changes
Other Study ID Numbers: Human sementstudie
First Submitted: May 14, 2007
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases