Bone Forming at Prosthetic Surfaces. Fingerprint2

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study

Conditions
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Osteo Arthritis

Intervention / Treatment
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* Device: Component for acetabulum (Regenerex RingLoc cup)
* Device: Components for the acetabulum (Lubinus cross linked cup)
* Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
* Device: Arthroplasty components are for the femur (Corail stem)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital. Exclusion Criteria: Systemic disease or medication affecting the skeleton

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regenerex<br> | Device: Component for acetabulum (Regenerex RingLoc cup)<br>* A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)<br>* Other names: Regenerex RingLoc cup;|
| Active Comparator: Lub cup<br> | Device: Components for the acetabulum (Lubinus cross linked cup)<br>* cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).<br>* Other names: Lubinus cross linked cup;|
| Active Comparator: SP II<br> | Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem)<br>* Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.<br>* Other names: Cemented Lubinus SP II stem;|
| Active Comparator: Corail<br> | Device: Arthroplasty components are for the femur (Corail stem)<br>* Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA).<br>* Other names: Uncemented HA-coated Corail stem with a ceramic 32 mm head;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, bone metabolism, mineralisation