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.
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
- 否
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)
