"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
NCT ID: NCT00473421
Last Updated: 2007-05-15
Study Results
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Basic Information
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UNKNOWN
PHASE1/PHASE2
INTERVENTIONAL
2007-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Barium Sulphate and Zirconium Oxide
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* systemic disease
50 Years
80 Years
ALL
No
Sponsors
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Ullevaal University Hospital
OTHER
Principal Investigators
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Lars Nordsletten, MD Ph.D
Role: STUDY_DIRECTOR
Ullevaal University Hospital
Jon Dahl, MD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal Univerity hospital
Locations
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Ullevaal university hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Flatoy B, Dahl J, Rohrl SM, Nordsletten L. Does radiopaque cement conceal periprosthetic bone loss around femoral stems? Hip Int. 2020 Nov;30(6):731-738. doi: 10.1177/1120700019863352. Epub 2019 Jul 30.
Other Identifiers
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Human sementstudie
Identifier Type: -
Identifier Source: org_study_id