No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Early and intermediate periprosthetic bone remodeling
研究概览
简要总结
The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
详细描述
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants
排除标准
- •infection, revision surgery, severe morbidity and obvious bone loss
研究组 & 干预措施
Bonemaster
Cement-less femoral stems with electrochemical deposition of hydroxyapatite
干预措施: Taperloc (Device)
Hydroxyapatite
Cement-less femoral stems with plasmasprayed hydroxyapatite
干预措施: Taperloc (Device)
结局指标
主要结局
Early and intermediate periprosthetic bone remodeling
时间窗: 5 years
Bone densitometry measured by DXA
Early and intermediate femoral stem stability
时间窗: 5 years
Radiostereometric analysis of femoral stem movements relative to bone
次要结局
- Clinical function(5 years)
- Radiographic signs of loosening(5 years)
研究者
Lars Nordsletten
Professor Lars Nordsletten
Oslo University Hospital