NCT03106558Unknown不适用
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Component alignment
研究概览
简要总结
This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires primary total knee surgery
- •Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- •Patient is willing to sign an IRB approved informed consent
- •Patient is at least 18 years of age
排除标准
- •Patient has a BMI > 50
- •Patient is skeletally immature
- •Patient has an active infection or suspected infection in or about the joint
- •Bone stock that is inadequate to support fixation of the prosthesis
- •Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Patients with mental or neurological conditions which may be incapable of following instructions.
- •Blood supply limitations
- •Collateral ligament insufficiency.
- •Patients with prior HTOs or Unis.
研究组 & 干预措施
Manual instrument total knee replacement
Active Comparator
干预措施: Total Knee Arthroplasty using Manual Instrumentation (Device)
Robitic arm total knee replacement
Active Comparator
干预措施: Total Knee Arthroplasty using Robotic Arm (Device)
结局指标
主要结局
Component alignment
时间窗: 6 weeks post knee arthroplasty
CT scan measurement
次要结局
未报告次要终点
研究者
研究点 (4)
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