ArthritisNCT00698672
RSA-Study of Cemented Hip Prostheses With Five Different Articulations
A study testing charnley OGEE, Spectron Reflection CoCr and Spectron XLPE CoCr in people with Arthritis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to compare wear and migration of the following hip prostheses: 1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component 2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput 3. Spectron EF stem with XLPE cup and 28 mm CoCr caput 4. Read more about this study
- Who is it for?
- Ages 59 to 80 years
- Conditions the study is for
- Arthritis
- What is being tested?
- charnley OGEE, Spectron Reflection CoCr and Spectron XLPE CoCr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2004to Jun 2017
- 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 59 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthritis
- dysplasia
Who cannot join
- obesitas
- charcots
- paget
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
The purpose of this study is to compare wear and migration of the following hip prostheses:
- Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
- Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
- Spectron EF stem with XLPE cup and 28 mm CoCr caput
- Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
- Spectron EF stem with XLPE cup and 28 mm Oxinium caput
Read the detailed description
Detailed description in:
Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients.
Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, Havelin LI, Stokke T, Haugan K, Espehaug B, Furnes O.
J Orthop Res. 2011 Aug;29(8):1222-9. doi: 10.1002/jor.21389
- Conditions
- Arthritis
- Being tested
- charnley OGEE, Spectron Reflection CoCr, Spectron XLPE CoCr, Spectron Reflection Oxinium
- Keywords
- RSA
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
charnley OGEEDevice
charnley OGEE
Spectron Reflection CoCrDevice
Spectron Reflection CoCr
Spectron XLPE CoCrDevice
Spectron XLPE CoCr
Spectron Reflection OxiniumDevice
Spectron Reflection Oxinium
Spectron XLPE CoCRDevice
Spectron XLPE CoCR
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized Receives: Device: Spectron Reflection CoCr |
| 3 | Active comparator | articulation Spectron Ef CoCr/ Reflection All-Poly XLPE Receives: Device: Spectron XLPE CoCr |
| 4 | Active comparator | articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized Receives: Device: Spectron Reflection Oxinium |
| 5 | Active comparator | articulation Spectron EF Oxinium/ Reflection XLPE Receives: Device: Spectron XLPE CoCR |
| 1 | Active comparator | articulation Charnley/ Ogee Receives: Device: charnley OGEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
wear
Measured: 2 years
Secondary outcomes (1)
migration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completionJun 2017 (estimated)
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 ArthritisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kadar, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698672
- Sponsor's protocol ID
- 10642(NSD)
- Other IDs
- 197.03(REK)
- Status last verified
- Feb 2017
- First submitted
- 16 Jun 2008
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not planned
Publications
Johannessen HG, Hallan G, Kadar T, Lie SA, Lygre SHL, Fenstad AM, Haugan K, Hol PJ, Badawy M, Jonsson B, Indrekvam K, Aamodt A, Furnes O. Early cup migration and wear as predictors for later aseptic loosening: a secondary evaluation of a randomized controlled RSA trial on cemented hip arthroplasties with 18-year follow-up. Acta Orthop. 2025 Aug 15;96:618-624. doi: 10.2340/17453674.2025.44328.
PubMed 40814981
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
- ClinicalTrials.gov ID
- NCT00698672
- Acronym / sponsor ID
- 10642(NSD)
- Conditions
- Arthritis
- Keywords
- RSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Jun 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 purpose of this study is to compare wear and migration of the following hip prostheses:
- Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
- Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
- Spectron EF stem with XLPE cup and 28 mm CoCr caput
- Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
- Spectron EF stem with XLPE cup and 28 mm Oxinium caput
Detailed description
Detailed description in:
Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients.
Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, Havelin LI, Stokke T, Haugan K, Espehaug B, Furnes O.
J Orthop Res. 2011 Aug;29(8):1222-9. doi: 10.1002/jor.21389
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Device: Spectron Reflection CoCrarticulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized |
| 3 | Active comparator | Device: Spectron XLPE CoCrarticulation Spectron Ef CoCr/ Reflection All-Poly XLPE |
| 4 | Active comparator | Device: Spectron Reflection Oxiniumarticulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized |
| 5 | Active comparator | Device: Spectron XLPE CoCRarticulation Spectron EF Oxinium/ Reflection XLPE |
| 1 | Active comparator | Device: charnley OGEEarticulation Charnley/ Ogee |
Who may qualify
- Ages
- 59 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- arthritis
- dysplasia
Key exclusion criteria (4 listed)
- obesitas
- charcots
- paget
- malignancy
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 |
|---|---|---|
| charnley OGEEcharnley OGEE | Device | 1 |
| Spectron Reflection CoCrSpectron Reflection CoCr | Device | 2 |
| Spectron XLPE CoCrSpectron XLPE CoCr | Device | 3 |
| Spectron Reflection OxiniumSpectron Reflection Oxinium | Device | 4 |
| Spectron XLPE CoCRSpectron XLPE CoCR | Device | 5 |
Primary outcome
wear
Time frame: 2 years
1 secondary outcome
migration
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Derived from this study: PubMed 40814981Johannessen HG, Hallan G, Kadar T, Lie SA, Lygre SHL, Fenstad AM, Haugan K, Hol PJ, Badawy M, Jonsson B, Indrekvam K, Aamodt A, Furnes O. Early cup migration and wear as predictors for later aseptic loosening: a secondary evaluation of a randomized controlled RSA trial on cemented hip arthroplasties with 18-year follow-up. Acta Orthop. 2025 Aug 15;96:618-624. doi: 10.2340/17453674.2025.44328.
- Individual participant dataSharing planned: No. Not planned
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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.
Thomas Kadar, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing charnley OGEE, Spectron Reflection CoCr and Spectron XLPE CoCr in people with Arthritis, run by Haukeland 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 2 inclusion and 4 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 28 Feb 2017. 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?
wear (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698672, 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 28 Feb 2017.