Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.
排除标准
- •Systemic disease or medication affecting the skeleton
研究组 & 干预措施
Regenerex
干预措施: Component for acetabulum (Regenerex RingLoc cup) (Device)
Lub cup
干预措施: Components for the acetabulum (Lubinus cross linked cup) (Device)
SP II
干预措施: Arthroplasty components are for the femur (Cemented Lubinus SP II stem) (Device)
Corail
干预措施: Arthroplasty components are for the femur (Corail stem) (Device)
结局指标
主要结局
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
时间窗: 6 weeks after surgery
There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group.
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
时间窗: 6 weeks after surgery
There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.
次要结局
- 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)