Arthritis of the HipNCT01693627
Cemented Marathon/Corail Versus Pinnacle/Corail
A study testing Pinnacle/Corail with collar, Marathon/Corail with collar and Pinnacle/Corail without collar in people with Arthritis of the Hip, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis: 1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and 2. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Arthritis of the Hip
- What is being tested?
- Pinnacle/Corail with collar, Marathon/Corail with collar and Pinnacle/Corail without collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Jan 2022
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.
Who cannot join
- Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
- BMI > 35,
- insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
- liver disease,
- Paget's disease,
- dementia or lack of compliance for other reasons,
- uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Orthopaedic Surgery, Haukeland University Hospital
Bergen, 5096
About this study
Official title: Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:
- Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and
- Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana)
Read more
There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total.
The aims of the study are:
- To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)
- To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)
- To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar
- Conditions
- Arthritis of the Hip
- Being tested
- Pinnacle/Corail with collar, Marathon/Corail with collar, Pinnacle/Corail without collar, Marathon/Corail without collar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinnacle/Corail with collarDevice
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Marathon/Corail with collarDevice
Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
Pinnacle/Corail without collarDevice
Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
Marathon/Corail without collarDevice
Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
| Study group | Role | What they receive |
|---|---|---|
| Pinnacle/Corail with collar | Active comparator | Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. Receives: Device: Pinnacle/Corail with collar |
| Marathon/Corail with collar | Active comparator | Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. Receives: Device: Marathon/Corail with collar |
| Pinnacle/Corail without collar | Active comparator | Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. Receives: Device: Pinnacle/Corail without collar |
| Marathon/Corail without collar | Active comparator | Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. Receives: Device: Marathon/Corail without collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyethylene wear
Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Measured: After 5 years of follow-up
Component migration-cup
Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Measured: After 5 years of follow-up
Periprosthetic bone mineral density
Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.
Measured: After 2 years of follow-up
Component migration-stem
Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
Measured: After 5 years of follow-up
Secondary outcomes (1)
Clinical outcome
Comparison of clinical results between study groups using HHS and PROMs
Measured: After 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2017 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of the 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leif I Havelin, MD, PhD, Study director, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, NorwayBenedikt A Jonsson, MD, Principal investigator, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, NorwayGeir Hallan, MD, PhD, Principal investigator, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, NorwayOve Furnes, MD, PhD, Study chair, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, NorwayClara G Gjesdal, MD, PhD, Study chair, Department of Rheumatology, Haukeland University Hospital, Bergen, NorwayKristin Haugan, MA, Study chair, Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, NorwayArne K Skredderstuen, MD, Study chair, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, NorwayTerje Stokke, Study chair, Department of Radiology, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693627
- Sponsor's protocol ID
- 2011/133
- Status last verified
- Feb 2016
- First submitted
- 21 Mar 2012
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry
- ClinicalTrials.gov ID
- NCT01693627
- Acronym / sponsor ID
- 2011/133
- Conditions
- Arthritis of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 26 Sep 2012 (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.
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:
- Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and
- Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana)
There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total.
The aims of the study are:
- To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)
- To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)
- To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pinnacle/Corail with collar | Active comparator | Device: Pinnacle/Corail with collarUncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. |
| Marathon/Corail with collar | Active comparator | Device: Marathon/Corail with collarReversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. |
| Pinnacle/Corail without collar | Active comparator | Device: Pinnacle/Corail without collarUncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. |
| Marathon/Corail without collar | Active comparator | Device: Marathon/Corail without collarReversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.
Key exclusion criteria (7 listed)
- Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
- BMI > 35,
- insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
- liver disease,
- Paget's 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 |
|---|---|---|
| Pinnacle/Corail with collarUncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. | Device | Pinnacle/Corail with collar |
| Marathon/Corail with collarReversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. | Device | Marathon/Corail with collar |
| Pinnacle/Corail without collarUncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone. | Device | Pinnacle/Corail without collar |
| Marathon/Corail without collarReversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone. | Device | Marathon/Corail without collar |
Primary outcome
Polyethylene wear
Time frame: After 5 years of follow-up
Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Component migration-cup
Time frame: After 5 years of follow-up
Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Periprosthetic bone mineral density
Time frame: After 2 years of follow-up
Differences in bone mineral density around a cemented and an uncemented acetabular component using Dual X-ray absorptiometry. Differences in bone mineral density around an uncemented fully HA-coated femoral component with or without a collar using Dual X-ray absorptiometry.
Component migration-stem
Time frame: After 5 years of follow-up
Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
1 secondary outcome
Clinical outcome
Time frame: After 5 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Leif I Havelin, MD, PhD study director
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Benedikt A Jonsson, MD principal investigator
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
Geir Hallan, MD, PhD principal investigator
Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pinnacle/Corail with collar, Marathon/Corail with collar and Pinnacle/Corail without collar in people with Arthritis of the Hip, 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 1 inclusion and 7 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 24 Feb 2016. 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?
Polyethylene wear (time frame: After 5 years of follow-up). The study lists 4 primary outcomes in all. 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 24 Feb 2016.