Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Femoral TKA component rotation in degrees
研究概览
简要总结
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.
详细描述
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
In agreement with our standard diagnostic algorithm for patients with pain and problems after TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees. The measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total Knee prosthesis (primary)
- •>55 years
排除标准
- •pregnancy
- •lactating women
研究组 & 干预措施
Kanekasu radiographs
No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique).
干预措施: Kanekasu radiographs (Other)
结局指标
主要结局
Femoral TKA component rotation in degrees
时间窗: one year
Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.
次要结局
- Inter- and intraobserver reliability of TKA femoral component rotation(one year)
研究者
Michael Tobias Hirschmann
PD Dr. med.
Kantonsspital Baselland Bruderholz