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临床试验/NCT02254980
NCT02254980进行中(未招募)不适用

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

Danderyd Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

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

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

Experimental

Vitamin-E diffused polyethylene

干预措施: Vitamin-E diffused polyethylene acetabular component (Device)

Control group

Active Comparator

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

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olof Skoldenberg

Consultant orthopedic surgeon

Danderyd Hospital

研究点 (2)

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