3D Motion Analysis of Evolution Medial Pivot Knee VS Posterior Stabilized Knee Arthroplasty for Osteoarthritis of the Knee.Feasibility Pilot for a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The motion analysis assessments of the knee
研究概览
简要总结
The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).
详细描述
Inclusion:
40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.
Patients who do not meet any exclusion criteria.
Exclusion:
Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria.
排除标准
- •Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded.
- •Exclusion for patient group
- •Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty.
- •Patients with any other joint replacement in the ipsilateral and contralateral limb.
- •Patients with evidence of active infection.
- •Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function.
- •Patients with neuropathic joints.
- •Patients requiring structural bone grafts.
- •Patients with a documented allergy to cobalt chromium molybdenum.
- •Patient with a BMI larger than 30 kg/m2.
结局指标
主要结局
The motion analysis assessments of the knee
时间窗: pre-op,6,12 months following surgery
次要结局
- Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey.(pre-op,6,12 and 24 months)