Results Between Robotic-Assisted and Manual Total Knee Arthroplasty With Kinematic Alignment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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 manual TKR or 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 manual TKR or 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
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •gonarthrosis
排除标准
- •heavy systemic diseases
研究组 & 干预措施
manual TKA
We prepare TKA using manual intrumentation
干预措施: postoperative Oxford Knee Score (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: postoperative CPAK (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: preoperative Oxford Knee Score (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: postoperative range-of-motion (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: preoperative Forgotten Joint Score (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: preoperative range-of-motion (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: postoperative HKA (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: preoperative HKA (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: preoperative CPAK (Other)
manual TKA
We prepare TKA using manual intrumentation
干预措施: postoperative Forgotten Joint Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: preoperative HKA (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: preoperative CPAK (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: preoperative Oxford Knee Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: preoperative Forgotten Joint Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: preoperative range-of-motion (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: postoperative HKA (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: postoperative CPAK (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: postoperative range-of-motion (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: postoperative Oxford Knee Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
干预措施: postoperative Forgotten Joint Score (Other)
结局指标
主要结局
HKA angle
时间窗: 3,6, 12 moths after surgery
HKA angle
时间窗: 3,6,12 months after surgery
measure pre and postoperative HKA angle
次要结局
未报告次要终点
研究者
Jakub Błaszczyk
doctor
Jan Biziel University Hospital No 2 in Bydgoszcz