Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Anterior-posterior translation of the femoral component with respect to the tibia component
研究概览
简要总结
Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.
Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in the XP vs. CR study (inherited traits from study inclusion)
- •Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
- •Are able to perform the tasks
- •Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)
排除标准
- •Knee pain above 20 on a 0-100 visual analogue scale
- •Any clinical relevant pain from adjacent joints
- •Active Knee flexion below 100
- •Signs of implant migration, loosening, and implant mal-alignment
研究组 & 干预措施
Total knee arthroplasty with Vanguard XP
The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.
干预措施: Total knee arthroplasty with Vanguard XP (Device)
Total knee arthroplasty with Vanguard XP
The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.
干预措施: Total knee arthroplasty with Vanguard CR (Device)
Total knee arthroplasty with Vanguard CR
Total knee arthroplasty system without preservation of the anterior cruciate ligament
干预措施: Total knee arthroplasty with Vanguard XP (Device)
Total knee arthroplasty with Vanguard CR
Total knee arthroplasty system without preservation of the anterior cruciate ligament
干预措施: Total knee arthroplasty with Vanguard CR (Device)
结局指标
主要结局
Anterior-posterior translation of the femoral component with respect to the tibia component
时间窗: at least one year post surgery
Group mean in millimeters (mm)
Axial rotation of the femoral component with respect to the tibia component
时间窗: at least one year post surgery
Group mean in degrees (°)
次要结局
- Velocity of center of pressure(at least one year post surgery)
- Isometric quadriceps muscle strength(at least one year post surgery)
- Rambling-trembling distance(at least one year post surgery)
- Traveled distance of center of pressure(at least one year post surgery)
研究者
Anders Troelsen
Professor, MD, PhD, dr.med
Hvidovre University Hospital