Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Improvement in Knee Society Knee Score
研究概览
简要总结
The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?
详细描述
Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 49 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
排除标准
- •Inflammatory disease
- •patient with other Lower extremity disease which may affect functional outcome
- •Neurologic disease effecting patients lower extremity
- •Revision surgery
- •Patient not medically cleared for bilateral surgery
研究组 & 干预措施
Non-Computer Assistance TKA
Non-Computer Assistance TKA
干预措施: Non-Computer Assistance TKA (Procedure)
Computer Assistance TKA
Computer Assistance TKA
干预措施: Computer Assistance TKA (Procedure)
结局指标
主要结局
Improvement in Knee Society Knee Score
时间窗: 10.5 years
change in knee score will be compared with initial score, until follow up of 10.5 years
次要结局
- Improvement in the range of motion(10.5 years)
研究者
Young Hoo Kim
Professor and Director
Ewha Womans University