Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 主要终点
- knee society knee score
研究概览
简要总结
To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.
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
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 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
结局指标
主要结局
knee society knee score
时间窗: 3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.
次要结局
- range of motion(preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years)
研究者
Young Hoo Kim
Professor
Ewha Womans University