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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
Information provided by:
Ullevaal University Hospital Identifier:
First received: May 14, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

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

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

Inclusion Criteria:

  • Osteoarthritis

Exclusion Criteria:

  • more than 80 yrs
  • systemic disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00473421

Contact: Jon Dahl +4791848655
Contact: Lars Nordsletten +4791721568

Ullevaal university hospital Recruiting
Oslo, Norway, 0407
Contact: Jon Dahl, MD    91848655   
Contact: Jon Dahl    91848655   
Sponsors and Collaborators
Ullevaal University Hospital
Study Director: Lars Nordsletten, MD Ph.D Ullevaal University Hospital
Principal Investigator: Jon Dahl, MD Ullevaal Univerity hospital
  More Information Identifier: NCT00473421     History of Changes
Other Study ID Numbers: Human sementstudie
Study First Received: May 14, 2007
Last Updated: May 14, 2007

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 25, 2017