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A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pinnacle/Corail with collar | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Comparison of clinical results between study groups using HHS and PROMs | After 5 years of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif I Havelin, MD, PhD | Department of Orthopeadic Surgery, Haukeland University Hospital, Bergen, Norway | Study Director |
| 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 | Principal Investigator |
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedic Surgery, Haukeland University Hospital | Bergen | 5096 | Norway |
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| Marathon/Corail with collar | Device | 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. |
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| Pinnacle/Corail without collar | Device | 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 collar | Device | 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. |
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