Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Change in Knee Society Knee Score
研究概览
简要总结
The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
详细描述
The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties
排除标准
- •inflammatory arthritis
- •osteoarthritis of the hip causing pain or restricted mobility
- •a foot or ankle disorder which limited walking
- •dementia or a neurological disorder including a past history of stroke which affected mobility
研究组 & 干预措施
NexGen CR knee prosthesis
side of knee operated with total knee replacement with Nexgen CR prosthesis
干预措施: Total knee replacement with NexGen CR knee prosthesis (Device)
NexGen CR-Flex knee prosthesis
side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis
干预措施: Total knee replacement(TKR) with Nexgen CR-flex (Device)
结局指标
主要结局
Change in Knee Society Knee Score
时间窗: baseline and 3 years
change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points
次要结局
未报告次要终点
研究者
Young Hoo Kim
Professor and Director
Ewha Womans University