Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- IKS 2011 Score measuring the clinical results of TKA
研究概览
简要总结
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).
Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.
The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.
The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis
- •Need for a total knee arthroplasty
排除标准
- •Age < 50 or > 80
- •Need for a different procedure than a TKA
- •Preoperative knee flexion < 90°
- •Need for a TKA associated with a combined femoral or tibial osteotomy
- •Knee already operated except for arthroscopy
- •Mediocre bone quality
研究组 & 干预措施
Cemented TKA
干预措施: Surgical total knee replacement using cemented components (Device)
Uncemented TKA
干预措施: Surgical total knee replacement using uncemented components (Device)
结局指标
主要结局
IKS 2011 Score measuring the clinical results of TKA
时间窗: One year postoperative
IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
次要结局
- Number of patients in each arm with radiological loosening signs of the TKA components(One year postoperative)