Primary and Secondary Osteoarthritis in HipPhase 1/2NCT00473421
"How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
A Phase 1/2 study testing Barium Sulphate and Zirconium Oxide in people with Primary and Secondary Osteoarthritis in Hip, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Primary and Secondary Osteoarthritis in Hip
- What is being tested?
- Barium Sulphate and Zirconium Oxide
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteNorway
- Study dates
- May 2007to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Osteoarthritis
Who cannot join
- more than 80 yrs
- systemic disease
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ullevaal university hospital
Oslo, 0407
Jon Dahl, MD, 91848655, jon.dahl@mac.com
Jon Dahl, 91848655, jon.dahl@mac.com
About this study
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.
Read more
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.
- Being tested
- Barium Sulphate and Zirconium Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barium Sulphate and Zirconium OxideProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary and Secondary Osteoarthritis in HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Nordsletten, MD Ph.D, Study director, Ullevaal University HospitalJon Dahl, MD, Principal investigator, Ullevaal Univerity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473421
- Sponsor's protocol ID
- Human sementstudie
- Status last verified
- May 2007
- First submitted
- 14 May 2007
- Last updated
- 15 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31359800
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "How do Contrast Medias in Bone Cement Affect DXA Measurements After THR"
- ClinicalTrials.gov ID
- NCT00473421
- Acronym / sponsor ID
- Human sementstudie
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- May 2007
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis
Key exclusion criteria (2 listed)
- more than 80 yrs
- systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barium Sulphate and Zirconium Oxide | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
- Derived from this study: PubMed 31359800Flatoy 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.
Related trials for Primary and Secondary Osteoarthritis in Hip
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Transforming Rehabilitation: Personalised Care for a Better Quality of Life
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Nordsletten, MD Ph.D study director
Ullevaal University Hospital
Jon Dahl, MD principal investigator
Ullevaal Univerity hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Barium Sulphate and Zirconium Oxide in people with Primary and Secondary Osteoarthritis in Hip, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon Dahl (+4791848655, jon.dahl@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2007; AzTrials last refreshed its copy on 31 Oct 2026.