Cemented Marathon/Corail Versus Pinnacle/Corail. Comparison of Polyethylene Wear, Component Migration and Periprosthetic Bone Mineral Density. A Randomised Study of 48 Hips Using Radiostereometry and Dual-energy X-ray Absorptiometry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Component migration-cup
研究概览
简要总结
A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:
- Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and
- Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana)
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:
- To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)
- To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)
- To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.
排除标准
- •Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
- •BMI > 35,
- •insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
- •liver disease,
- •Paget's disease,
- •dementia or lack of compliance for other reasons,
- •uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.
结局指标
主要结局
Component migration-cup
时间窗: After 5 years of follow-up
Comparison of the migration of a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis.
Component migration-stem
时间窗: After 5 years of follow-up
Comparison of the migration of an uncemented fully HA-coated femoral component with and without a collar using radiostereometric analysis.
Polyethylene wear
时间窗: After 5 years of follow-up
Comparison of polyethylene wear rates in a modular uncemented acetabular component and a cemented all-polyethylene acetabular component using radiostereometric analysis
Periprosthetic bone mineral density
时间窗: After 2 years of follow-up
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.
次要结局
- Clinical outcome(After 5 years of follow-up)