The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Muscle strength measurement changes after TKA
研究概览
简要总结
The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.
详细描述
A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;
排除标准
- •Those who do not meet the inclusion criteria;
- •Neuromuscular dysfunction;
- •Diseases affecting postoperative efficacy evaluation
结局指标
主要结局
Muscle strength measurement changes after TKA
时间窗: 1,3,6,12 months after TKA
Strength measurement of related muscles according to Lovett muscle strength grading standard.
HSS score changes after TKA
时间窗: 1,3,6,12 months after TKA
Summed Hospital for special surgery (HSS) score with a maximum score of 100. Higher values represent a better outcome.
KSS score changes after TKA
时间窗: 1,3,6,12 months after TKA
Summed Knee Society Score (KSS) score with a maximum score of 100. Higher values represent a better outcome.
X-ray evaluation changes after TKA
时间窗: 1,3,6,12 months after TKA
Evaluation of postoperative X-ray results for lower limb line, prosthesis location and other conditions
次要结局
未报告次要终点
研究者
Yanzhao
Principal Investigator
Xijing Hospital