Highly Cross-linked Polyethylene Versus Compression Mold Conventional Polyethylene in Cruciate-substituting Total Knee Arthroplasty in Young Patients, a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Knee society knee score
研究概览
简要总结
The aim of this study was to determine clinical and radiographic results after posterior cruciate-substituting total knee arthroplasties with highly cross-linked polyethylene in one knee and compression mold conventional polyethylene in the contralateral knee in the same patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Younger than 65 years old
- •with end stage knee arthritis bad enough for knee replacement
排除标准
- •inflammatory arthritis
- •combined foot and ankle disorders.
- •patient older than 65 years old.
研究组 & 干预措施
HXLPE
This side of knee implanted with HXLPE(highly crosslinked polyethylene) liner while undergoing total knee arthroplasty. This group will receive the intervention, "Total knee arthroplasty with HXLPE liner".
干预措施: Total knee arthroplasty with HXLPE liner (Procedure)
Conventional
This side of knee implanted with conventional polyethylene while undergoing standard total knee arthroplasty. This group will receive the intervention, "Total knee arthroplasty with conventional polyethylene liner".
干预措施: Total knee arthroplasty with conventional polyethylene liner (Procedure)
结局指标
主要结局
Knee society knee score
时间窗: minimum 10 year follow up after the index surgery
a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function
次要结局
- WOMAC(Western Ontario and McMaster Universities) Scores(minimum 10 year follow up after the index surgery)
- Range of motion(minimum 10 year follow up after the index surgery)
研究者
Young Hoo Kim
Professor
Ewha Womans University