- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693627
Cemented Marathon/Corail Versus Pinnacle/Corail
February 23, 2016 updated by: Haukeland University Hospital
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)
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 Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bergen, Norway, 5096
- Department of Orthopaedic Surgery, Haukeland University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pinnacle/Corail with collar
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.
|
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.
|
Active Comparator: Marathon/Corail with collar
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.
|
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.
|
Active Comparator: Pinnacle/Corail without collar
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.
|
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.
|
Active Comparator: Marathon/Corail without collar
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
After 5 years of follow-up
|
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.
|
After 5 years of follow-up
|
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.
|
After 2 years of follow-up
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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.
|
After 5 years of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcome
Time Frame: After 5 years of follow-up
|
Comparison of clinical results between study groups using HHS and PROMs
|
After 5 years of follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Leif I Havelin, MD, PhD, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
- Principal Investigator: Benedikt A Jonsson, MD, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
- Principal Investigator: Geir Hallan, MD, PhD, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
- Study Chair: Ove Furnes, MD, PhD, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
- Study Chair: Clara G Gjesdal, MD, PhD, Department of Rheumatology, Haukeland University Hospital, Bergen, Norway
- Study Chair: Kristin Haugan, MA, Department of Orthopeadic Surgery, Trondheim University Hospital, Trondheim, Norway
- Study Chair: Arne K Skredderstuen, MD, Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway
- Study Chair: Terje Stokke, Department of Radiology, Haukeland University Hospital, Bergen, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
March 21, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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