Arthritis of the Hip Clinical Trial
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
Verified date | February 2016 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Commitee |
Study type | Interventional |
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. 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
Status | Active, not recruiting |
Enrollment | 61 |
Est. completion date | January 2022 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Department of Orthopaedic Surgery, Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Polyethylene wear | 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 | No |
Primary | Component migration-cup | 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 | No |
Primary | 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. | After 2 years of follow-up | No |
Primary | Component migration-stem | 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 | No |
Secondary | Clinical outcome | Comparison of clinical results between study groups using HHS and PROMs | After 5 years of follow-up | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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