NCT05365022Unknown不适用
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.
Borja Alcobía-Díaz MD, PhD2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
研究概览
简要总结
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis requiring PS Knee Prosthesis
排除标准
- •Not meeting Inclusion Criteria
- •Requiring Constrained Prosthesis
- •Metal Allergy
- •Neurological disorders.
- •Cognitive impairment
- •Not giving consent.
结局指标
主要结局
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
时间窗: 6 months after surgery
Correct lower limb mechanical alignment
次要结局
- Technique reproducibility between surgeons(Intraoperative)
- Time to Recovery(1 year after surgery)
- Patient satisfaction(1 year after surgery)
- Pain Control(1 year after surgery)
- Time to home discharge(1 month)
- Implant Stability(1 year after surgery)
- Mobility(1 year after surgery)
- Complications(1 year after surgery)
- Technique Timing at Operating Room (OR)(Intraoperative)
研究者
Borja Alcobía-Díaz MD, PhD
MD, PhD. Clinical Professor
Hospital San Carlos, Madrid
研究点 (2)
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