Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Migration of femur- and acetabular prosthesis measured by RSA
研究概览
简要总结
Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis
In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.
The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coxarthrosis
排除标准
- •age over 80
- •major medial condition such as renal failure, chronic obstructive lung disease heart failure etc
结局指标
主要结局
Migration of femur- and acetabular prosthesis measured by RSA
时间窗: 2008-2012
次要结局
- Periprosthetic osteolysis of proximal femur(2008-2012)