Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
研究概览
简要总结
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments
详细描述
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
- •Subjects willing to return for follow-up evaluations
排除标准
- •Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
- •Severe OA deformation (FTA: >185 degrees or <175 degrees)
- •Active Infection (or within 6 weeks after infection)
- •Osteomyelitis
- •Any type of implant is inserted in the affected side of lower extremity
- •Hip disease on the affected side
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- •diagnosed Osteoporosis or Osteomalacia
- •Metabolic disorders which may impair bone formation
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy or neuromuscular disease.
研究组 & 干预措施
Vanguard with KneeAlign 2
Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
干预措施: KneeAlign 2 (Device)
Vanguard without KneeAlign 2
Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
结局指标
主要结局
Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
时间窗: Postoperative 6 months
Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.
次要结局
- Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold(Postoperative 6 months)
- Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold(Postoperative 6 months)
- Number of Participants With Adverse Events and/or Adverse Device Effects(Intra-operative and Post-operative 6 months)