Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Knee Flexion
研究概览
简要总结
Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.
详细描述
The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).
For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).
Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.
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
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for TKA with a non-linked, bicondylar total knee replacement
- •written informed consent
排除标准
- •Chronic pain patients
- •Neuromuscular Diseases
- •general illnesses that make mobilisation more difficult and/or prevent follow-up
- •Known posterior cruciate ligament insufficiency
- •Need for a higher degree of linkage
- •BMI over 40 kg/m²
- •Study doctor, his family, employees or other dependent persons
研究组 & 干预措施
PS
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
干预措施: PS TKA (Device)
CR
Implantation of a cruciate retaining Total Knee Arthroplasty.
干预措施: CR TKA (Device)
结局指标
主要结局
Knee Flexion
时间窗: 1 year after surgery
Knee flexion measured using a goniometer
次要结局
- Function assessed by the Knee Society Score(10 years after surgery)
- Patient Reported Outcome(10 years after surgery)
- Health-related Quality of Life(10 years after surgery)
- Activity assessed by UCLA activity score(10 years after surgery)