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临床试验/NCT04126421
NCT04126421已完成不适用

Vitamin E Stabilized Highly Cross-linked Polyethylene in Reversed Hybrid Total Hip

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Migration of prothesis components

研究概览

简要总结

A prospective randomized controlled study evaluating the wear and migration of cemented acetabular sockets with third generation highly cross-linked vitamin E infused polyethylene and second generation highly crosslinked UHMWPE using Radiostereometric Analysis (RSA).

详细描述

Background Reducing the rate of polyethylene (PE) wear in acetabular sockets and thereby increasing the lifespan of Total Hip Arthroplasty (THA) has been a major concern in the orthopaedic community for decades. Wear of PE and osteolysis followed by late aseptic loosening of the prosthesis is the main reason for revision surgery after THA in Norway.

During 2008 in Norway 805 out of a total of 1114 revised THA were subjugated to surgery due to aseptic loosening or osteolysis without loosening. The DRG (Diagnose Related Grouping) weight is 5.49 for secondary THA and every DRG point has a value of 33.647 NOK adding up to a direct total cost for revision after aseptic loosening of approximately 27 million USD.

Caput prosthesis with a diameter of 32mm or more has the major advantage to increase the Range of Motion (ROM) and to reduce the risk of dislocation of the hip but, the larger the caput prosthesis the more adhesive wear can be expected. This and the relative failure of metal on PE gave the incentive to develop and take into clinical practise bearings with increased resilience to wear. Today, there exists a wide range of options with a substantially lower rate of volumetric wear compared to conventional PE. The biological and immunological in vivo response to wear particles is very complicated and only partially understood. It is clear that host response to wear particles and the corrosion products play a major role in osteolysis around the prosthesis. For metal-on-metal (MoM) bearings the volumetric wear is a magnitude less but the number of particle debris is massively increased. MoM also have the problem with possible teratogen effect and allergy or hypersensitivity side effects. Ceramic on ceramic (cer-cer) has the lowest wear rate of any artificial articulations, but it is still possible to detect biologically active debris particles. Cer-cer also has other challenges including fracture of prosthesis, squeaking hip, narrow margins for placing components and cost.

Polyethylene is a thermoplastic polymer consisting of long chains of the monomer ethylene (C2H4). The mechanical properties of PE depend on variables such as the extent and type of branching and the crystal structure etc.

To improve the wear resistance of the PE an increase in the cross-linking between the chains of polyethylene can be achieved by exposing it to high-energy irradiation. The irradiation also increases the unpaired free electrons (free radicals). Free radicals can react with oxygen and start a chain reaction causing an oxidative degradation of the polyethylene and consequently cause increased wear. 1st generation HXLPE sockets have reduced the mid term incidence of particle-induced osteolysis but retrieved failed first-generation HXLPE sockets have shown surface cracking and signs of in vivo oxidative degradation.

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
Double (Participant, Care Provider)

入排标准

年龄范围
— 至 74 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients under the age of 75 with primary or secondary arthrosis scheduled for total hip arthroplasty.

排除标准

  • a major anatomical deviation, immunosuppressive medication or a significant systemic disease.

结局指标

主要结局

Migration of prothesis components

时间窗: 5 years

Migration of prothesis components using radiosterometric analysis of hip x-rays (RSA)

次要结局

  • HHS (Patient reported outcome measure (PROMs))(10 years)
  • EQ-5D (Patient reported outcome measure (PROMs))(10 years)
  • VAS pain (Patient reported outcome measure (PROMs))(10 years)
  • WOMAC (Patient reported outcome measure (PROMs))(10 years)

研究者

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

Peder Svenkerud Thoen

MD, Consultant Orthopedic Surgery

Oslo University Hospital

研究点 (2)

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