NCT00132587已完成不适用
Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- IKS (International Knee Society) score at 12 months
研究概览
简要总结
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.
One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.
Patients will be reviewed at 2, 6 and 12 months.
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
- Single
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
- •Indication of surgical treatment by total knee arthroplasty
- •Age between 50 and 90 years
- •Acceptance and signature to participate
排除标准
- •Rheumatoid or other inflammatory arthritis
- •Association with other surgical procedure (osteotomy)
- •Range of motion inferior to 90°
- •Previous knee surgery (except arthroscopy)
结局指标
主要结局
IKS (International Knee Society) score at 12 months
次要结局
- Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
研究者
研究点 (2)
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