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临床试验/NCT00837850
NCT00837850已完成不适用

A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.

Norwegian University of Science and Technology0 个研究点目标入组 35 人开始时间: 2002年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
主要终点
Distal migration of the charnley femoral stem

研究概览

简要总结

A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

详细描述

The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.

Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

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
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients in need for total hip arthroplasty

排除标准

  • patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
  • patients on corticosteroid treatment,
  • patients who had already participated in a clinical study with an investigational product in the last 6 months.

结局指标

主要结局

Distal migration of the charnley femoral stem

时间窗: 2010

次要结局

  • Rotational movements of the charnley femoral stem(2010)

研究者

申办方类型
Other
责任方
Sponsor

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