Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Cup migration
研究概览
简要总结
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.
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
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip
- •Willingness and ability to follow study-protocol
排除标准
- •Inflammatory arthritis or secondary osteoarthritis.
- •Type C (stove pipe) femur
- •Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
- •Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
- •Ongoing oestrogen treatment
- •Not suited for the study for other reason (surgeons preference)
研究组 & 干预措施
Vitamin-E group
Vitamin-E diffused polyethylene
干预措施: Vitamin-E diffused polyethylene acetabular component (Device)
Control group
Standard polyethylene
干预措施: Standard polyethylene acetabular component (Device)
结局指标
主要结局
Cup migration
时间窗: 2 years
The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
次要结局
- Complication rate(10 years)
- Cup migration total(2 years)
- Linear wear(4 years)
- Functional outcome(2 years)
- Osteolysis(2 years)
研究者
Olof Skoldenberg
Consultant orthopedic surgeon
Danderyd Hospital
