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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00473421
First received: May 14, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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: Open Label
Primary Purpose: Treatment

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Further study details as provided by Ullevaal University Hospital:

Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Osteoarthritis

Exclusion Criteria:

  • more than 80 yrs
  • systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00473421     History of Changes
Other Study ID Numbers: Human sementstudie
Study First Received: May 14, 2007
Last Updated: May 14, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Barium Sulfate
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014