跳至主要内容
临床试验/NCT01637051
NCT01637051进行中(未招募)不适用

The Importance of Different Modularity of the Polyethylene Insert for Tibial Component Migration and Adaptive Bone Remodeling After Uncemented Total Knee Arthroplasty Using Trabecular Metal Technology (TMT) Zimmer NexGen®, (Monoblock vs. Modular Design)

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年7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)
入组人数
60
试验地点
1
主要终点
migration of tibial component

研究概览

简要总结

In a prospective randomised study two uncemented tibial components with different polyethylene modularities (Trabecular Metal Technology (TMT) Zimmer NexGen® monobloc and TMT Zimmer NexGen® modular) used for total knee arthroplasty (TKA) is evaluated. Both tibial component coatings are designed to provide excellent condition for bone ingrowth.

The differences between the two tibial components are evaluated by measurements of migration of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry (DEXA).

详细描述

Introduction In general a primary TKA is a durable and well-functioning solution with a 10-year implant survival of more than 90 % (Robertsson et al. 2001). Both implants to be tested in the present study have a trabecular metal coating of the tibial component. However, a different manufacturing technique of the baseplate with one having a monoblock polyethylene insert and the other a modular polyethylene insert have been used. Failure secondary to polyethylene wear is ranked as a frequent cause for revision. Many issues have been identified as contributory to polyethylene wear; the quality of the polyethylene, manufacturing process, nature of the tibial-femoral or patellofemoral articulation, area of contact, sterilization process, and issues pertaining to modularity (backside wear) (Lombardi et al. 2004, Lombardi et al. 2008). Long-term clinical studies have documented the success of direct compression-molded monoblock tibial components (Weber et al. 2002). However, the benefits of modularity are widely recognized and include the ability to fine tune soft-tissue balance after implantation of metallic devices.

New techniques are developed and the patients´ demands for increased durability of the implants are increasing. Failure because of aseptic loosening of the tibia component remains one of the leading courses of revision surgery in TKA (Sierra et al. 2004, Danish Knee Arthroplasty Register, Annual Report 2010). It is believed that both the implants, planned to be tested in the present study, with the trabecular surface coating will facilitate bone ingrowth and secure a better fixation to the host bone, thus increasing the implant survival and improving the function of the prosthesis.

One of the implants NexGen® , monoblock(TMT) has been used for routine clinical use abroad, but also in Denmark for some years, and so far the clinical results have been good (Bobyn et al. 2004). There have been made two randomized controlled studies using RSA mesurement of the implant showing promising results with good stable fixation at follow up between twelve and twenty-four month (Dunbar et al. 2009, Henricson et al. 2008).

The other type of prosthesis is identical but has a modular polyethylene design of the tibia component. Modular designs are used frequently in most TKA designs and have also shown good long-term results. However, there are potential problems concerning back-side wear and aseptic loosening because of polyethylene foreign body reaction (Lombardi et al. 2004, Lombardi et al. 2008, Weber et al. 2002).

There have been made previous randomized RSA studies evaluating uncemented modular TKA designs with good results showing stable fixation at twelve and twenty-four month (Dunbar et al. 2008, Hansson et al. 2005, Hansson 2008).

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
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The participants of the study are patients that have been scheduled for a primary TKA using the usual indications for TKA at the Department of Planned Elective Surgery Z, Gentofte Hospital.
  • •Inclusion Criteria:
  • •Severe osteoarthrosis of the knee with indication for a TKA.
  • •Age between 40 and 70 years.

排除标准

  • •Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.).
  • •Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.

研究组 & 干预措施

Zimmer NexGen®, Trabecular Metal Technology (TMT) Monoblock

Other

The tibial component has a monoblock design

干预措施: Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock (Device)

Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

Other

The tibial component has a modular design

干预措施: Zimmer NexGen® Trabecular Metal Technology (TMT), Modular (Device)

结局指标

主要结局

migration of tibial component

时间窗: three years

The differences between two tibial components are evaluated by measurements of migration of the tibial component assesed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assesed by dual energy X-ray absorpitiometry (DEXA).

次要结局

  • Knee function(three years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikkel Rathsach Andersen

Læge, Ph.D

Rigshospitalet, Denmark

研究点 (1)

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