Comparison Between Velys J&J Robotic-assisted and Cori S&N Robotic-assisted Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. HKA angle
研究概览
简要总结
This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either Velys J&J robotic-assisted or Cori S&N robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.
详细描述
This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either Velys J&J robotic-assisted or Cori S&N robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gonarthrosis
排除标准
- •heavy systemic diseases
研究组 & 干预措施
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: preoperative HKA (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: preoperative CPAK (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: preoperative Oxford Knee Score (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: preoperative Forgotten Joint Score (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: preoperative range-of-motion (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: postoperative Forgotten Joint Score (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: postoperative range-of-motion (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: postoperative Oxford Knee Score (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: postoperative Forgotten Joint Score (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: preoperative HKA (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: preoperative CPAK (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: preoperative Oxford Knee Score (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: preoperative Forgotten Joint Score (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: preoperative range-of-motion (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: postoperative HKA (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: postoperative CPAK (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: postoperative range-of-motion (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: postoperative HKA (Other)
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
干预措施: postoperative CPAK (Other)
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
干预措施: postoperative Oxford Knee Score (Other)
结局指标
主要结局
1. HKA angle
时间窗: before and 3,6,12 after surgery
CPAK
时间窗: before and 3,6,12 months after surgery
range-of-motion
时间窗: before and 3,6,12 moths after surgery
次要结局
- Oxford Knee Score(before and 3,6,12 months after surgery)
- Forgotten Joint Score(before and 3,6,12 moths after surgery)
研究者
Jakub Błaszczyk
Doctor
Jan Biziel University Hospital No 2 in Bydgoszcz