跳至主要内容
临床试验/NCT01936415
NCT01936415已完成4 期

The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive Bone Remodeling in Uncemented Total Knee Arthroplasty (Vanguard Versus Regenerex)

Hillerod Hospital, Denmark2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Migration of the tibial component

研究概览

简要总结

In a prospective randomised study two uncemented tibial components with different coating (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component coatings are designed to provide excellent conditions 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

In general a primary TKA is a durable and well-functioning solution with a 10-year implant survival of more than 90 %. However, new techniques are developed and the patients´ demands for increased durability of the implants are increasing. It is believed that the new implant Regenerex, planned to be tested in the present study, with the new 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 (Vanguard) has been used for routine clinical use abroad, but also in Denmark for some years, and so far the results have been good.

The other type coating (Regenerex) is a micro-casting of the structure of normal trabecular bone, but made from metal alloy, in the element Titanium. Titanium is also very biocompatible (Hoffman 1993, Hahn, H 1970) and have been used with great success in e.g. uncemented total hip arthroplasy for several years (Marshall et al. 2004, Meding et al, 2004).

Trabecular metal has a porosious structure close to that of normal trabecular bone, and the biomechanical characteristics such as e.g. compressive strength and elastic modulus are very close to that of normal trabecular bone (Krygier et al. 1999, Zardiackas 2001). These characteristics are the reason why trabecular metal within the past decade have been used for production of different orthopedic implants, and the early clinical results so far have been very promising (Bobyn et al. 2004, Nasser & Poggie 2004, Nehma et al. 2004, Nelson et al. 2003).

Quantitative measurements of the implant migration and adaptive bone remodeling of the bone close to the implants are generally accepted as suitable methods for an objective evaluation of the effect of joint replacement surgery and have been proposed as mandatory important examinations that must bee performed before new implants are distributed for wide-spread use (Bobyn et al. 2004, Petersen & Schrøder 2004, Østgaard & Nielsen 2004).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe osteoarthrosis of the knee with indication for a TKA.
  • Age between 18 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.
  • Premenopausal women.

结局指标

主要结局

Migration of the tibial component

时间窗: three years

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). The differens is messured in millimeters.

次要结局

未报告次要终点

研究者

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

Nikolaj Winther

Pricipal Incestigatior. MD, Consultant in Orthopeadic.

Hillerod Hospital, Denmark

研究点 (2)

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