An Investigation of Total Knee Arthroplasty Kinematics on Patient Performance - The Zimmer Legacy® LPS Flex Knee System
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)
研究概览
简要总结
To determine clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study will provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.
详细描述
The objective of this study is to determine the clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. Pre and post-operative clinical and gait variables will be compared within the computer-assisted group. These same comparisons will also be made between the computer-assisted surgical group and a conventional surgical group who receive the same knee implant. This study will further provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.
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
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
- •age 50-80
- •undergoing primary total knee arthroplasty
- •femoral tibial varus < 7 degrees
- •no previous joint infections
- •anteriorcruciate ligament intact
- •clinically significant patellofemoral or osteoarthritic degeneration
排除标准
- •active articular infections
- •significant concurrent ipsilateral hip osteoarthritis
- •chronic pain syndrome requiring medications for control
- •history of chemical addiction
- •significant spinal stenosis, chronic back pain, sciatica
- •patients who are unlikely to comply with, participate in or return for follow-up visits as described in the protocol
- •osteomyelitis, septicemia or other infections that may spread to other areas of the body
- •highly communicable diseases, immuno-compromising conditions and/or that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
- •diabetic neuropathy
- •skeletal immaturity
- •decreased mental comprehension and literacy
- •pregnancy
结局指标
主要结局
Gait kinetic and kinematic parameters at the knee (knee forces, moments and angles)
时间窗: pre-op and 1 year
次要结局
- knee pain, stiffness and function(preop- 1 and 2 years)
研究者
Dr. John Rudan
Principal Investigator
Queen's University