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What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?
A clinical study of 26 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in four groups plus a reference group of same 26 patient´s contralateral healthy hip.
Intervention will be surgery with a total hip arthroplasty. The studied endoprosthetic components are: Cemented Lubinus SP II stem with a ceramic 32 mm head, a cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). Palacose cement with gentamycin, applied with 3:rd generation cementation technique will be used for those cemented implants.
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnson & Johnson, USA), a fibrous metal Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) All cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).
Clinical score, radiography and PET uptake of Fluoride tracer (SUV) adjacent to the prosthetic surfaces will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenerex | Active Comparator |
| |
| Lub cup | Active Comparator |
| |
| SP II | Active Comparator |
| |
| Corail | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Component for acetabulum (Regenerex RingLoc cup) | Device | A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEMUR: to analyze difference in SUV of the 4 upper ROI's (No 1, 7, 8 and 13) analyzed together between the cemented and uncemented groups AND: to analyze SUV of the 4 upper ROI's analyzed together between each femur study group and the reference group | There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group. | 6 weeks after surgery |
| ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group | There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group. | 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group | 6 weeks and 6 months | |
| FEMUR: to analyze difference in SUV for each individual ROI between the cemented study group and the reference group. To analyze difference in SUV for each individual ROI between the uncemented study group and the reference group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gösta Ullmark, MD, PhD | Contact | +46706466149 | gosta.ullmark@lg.se |
| Name | Affiliation | Role |
|---|---|---|
| Gösta Ullmark | Ass Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for research and development Uppsala university/County council of Gävleborg | Recruiting | Gävle | 80187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32686502 | Derived | Ullmark G, Sorensen J, Nilsson O, Maripuu E. Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2020 Nov;30(6):745-751. doi: 10.1177/1120700019861274. Epub 2020 Jul 19. | |
| 30520317 | Derived | Ullmark G, Sorensen J, Maripuu E, Nilsson O. Fingerprint pattern of bone mineralisation on cemented and uncemented femoral stems: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2019 Nov;29(6):609-617. doi: 10.1177/1120700018815404. Epub 2018 Dec 6. |
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| Components for the acetabulum (Lubinus cross linked cup) | Device | cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). |
|
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| Arthroplasty components are for the femur (Cemented Lubinus SP II stem) | Device | Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head. |
|
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| Arthroplasty components are for the femur (Corail stem) | Device | Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA). |
|
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| 6 weks and 6 months |
| FEMUR:to analyze difference in SUV for each individual ROI between the 3 time points for the cemented group. To analyze difference in SUV for each individual ROI between the 3 time points for the uncemented group. | preoperatively, 6 weeks and 6 months |
| FEMUR:to analyze difference in SUV for the 4 upper ROI's (No 1, 7, 8 and 13)analyzed together between the 2 study groups | 6 months |
| FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group | 6 months |
| ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups | 6 weeks and 6 months |
| ACETABULUM: to analyze difference in SUV for each individual ROI between the cemented study group and the reference group. To analyze difference in SUV for each individual ROI between the uncemented study group and the reference group. | 6 weeks and 6 months |
| ACETABULUM: to analyze difference in SUV for each individual ROI for the cemented study group between the 3 time points. To analyze difference in SUV for each individual ROI for the uncemented study group between the 3 time points. | preoperatively, 6 weeks and 6 months |
| ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups | 6 months |
| ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group | 6 months |