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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
Centre for research and development Uppsala university/County council of Gävleborg
Gävle, Sweden
RECRUITINGFEMUR: 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.
Time frame: 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.
Time frame: 6 weeks after surgery
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).
FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group
Time frame: 6 months
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 6 months