NCT00375856已完成4 期
An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 5
- 主要终点
- Gait and radiographic parameters
研究概览
简要总结
Primary Research Questions:
- Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee?
- Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)?
- Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-75 years
- •Undergoing primary total knee arthroplasty
- •Clinically significant osteoarthritic degeneration
排除标准
- •Active articular infections
- •Bilateral knee replacement (simultaneous)
- •Previous joint infections
- •Significant concurrent ipsilateral hip osteoarthritis
- •Chronic pain syndrome requiring medications for control
- •History of chemical addiction
- •Significant spinal stenosis, significant symptomatic 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 conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
- •Decreased mental comprehension and literacy
- •Prior high tibial osteotomy
- •Prior patellectomy
- •Rheumatoid arthritis
- •Pregnancy
结局指标
主要结局
Gait and radiographic parameters
时间窗: 0
次要结局
- Knee pain, function(0)
研究者
Dr. John Rudan
Principal Investigator
Queen's University
研究点 (5)
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