"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
Primary Purpose
Primary and Secondary Osteoarthritis in Hip
Status
Unknown status
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Barium Sulphate and Zirconium Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Primary and Secondary Osteoarthritis in Hip
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis
Exclusion Criteria:
- more than 80 yrs
- systemic disease
Sites / Locations
- Ullevaal university hospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00473421
First Posted
May 14, 2007
Last Updated
May 14, 2007
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00473421
Brief Title
"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary and Secondary Osteoarthritis in Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Barium Sulphate and Zirconium Oxide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis
Exclusion Criteria:
more than 80 yrs
systemic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Dahl
Phone
+4791848655
Email
jon.dahl@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Nordsletten
Phone
+4791721568
Email
lars.nordsletten@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, MD Ph.D
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jon Dahl, MD
Organizational Affiliation
Ullevaal Univerity hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ullevaal university hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Dahl, MD
Phone
91848655
Email
jon.dahl@mac.com
First Name & Middle Initial & Last Name & Degree
Jon Dahl
Phone
91848655
Email
jon.dahl@mac.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31359800
Citation
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.
Results Reference
derived
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"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
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