Primary ArthrosisNCT00804388
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
A study testing Total hip arthroplasty in people with Primary Arthrosis and Osteoarthritis, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA. The polyethylene to be used is E-Poly (Biomet). Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Primary Arthrosis, Osteoarthritis
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2008to Feb 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-65 years old
- Primary or secondary osteoarthritis
Who cannot join
- Significant anatomical divergence are excluded
- Rheumatoid arthritis
- Fracture sequelae
- Dysplasia
- Immune suppression or grave systemic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.
The polyethylene to be used is E-Poly (Biomet).
The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.
Read the detailed description
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.
- Conditions
- Primary Arthrosis, Osteoarthritis
- Being tested
- Total hip arthroplasty
- Keywords
- Vitamine E, E-poly, Hip, Degenerative joint disease
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Also called E-poly, Vitamine E, Hip, degenerative joint disease
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Uncemented total hip replacement, 32 mm caput Receives: Procedure: Total hip arthroplasty |
| 2 | Active comparator | Uncemented total hip replacement, 36 mm caput Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure polyethylene wear and bone mineral density between the two groups
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ArthrosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, Zimmer Biomet, Ullevaal University Hospital
- Investigators
- Stephan M. Røhrl, MD,PhD, Study chair, Ullevål Univeristy Hospital NorwayEinar Lindalen, MD, Study chair, Lovisenberg Diakonale sykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804388
- Sponsor's protocol ID
- S-08366a
- Other IDs
- 03-2008 LDS
- Status last verified
- Jan 2011
- First submitted
- 5 Dec 2008
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
- ClinicalTrials.gov ID
- NCT00804388
- Acronym / sponsor ID
- S-08366a
- Conditions
- Primary Arthrosis, Osteoarthritis
- Keywords
- Vitamine E, E-poly, Hip, Degenerative joint disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost, Zimmer Biomet, Ullevaal University Hospital
- Study start
- Dec 2008
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 8 Dec 2008 (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.
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.
The polyethylene to be used is E-Poly (Biomet).
The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.
Detailed description
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Total hip arthroplastyUncemented total hip replacement, 32 mm caput |
| 2 | Active comparator | Procedure: Total hip arthroplastyUncemented total hip replacement, 36 mm caput |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-65 years old
- Primary or secondary osteoarthritis
Key exclusion criteria (5 listed)
- Significant anatomical divergence are excluded
- Rheumatoid arthritis
- Fracture sequelae
- Dysplasia
- Immune suppression or grave systemic illness
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 |
|---|---|---|
| Total hip arthroplastyAlso: E-poly, Vitamine E, Hip, degenerative joint disease32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene | Procedure or surgery | 1, 2 |
Primary outcome
Measure polyethylene wear and bone mineral density between the two groups
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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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.
Stephan M. Røhrl, MD,PhD study chair
Ullevål Univeristy Hospital Norway
Einar Lindalen, MD study chair
Lovisenberg Diakonale sykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty in people with Primary Arthrosis and Osteoarthritis, run by Lovisenberg Diakonale 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 2 inclusion and 5 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 7 Jan 2011. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure polyethylene wear and bone mineral density between the two groups (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2011.