Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
研究概览
简要总结
Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for a TKA with a fixed-bearing total knee endoprosthesis
- •Written informed consent for participating in the clinical study
排除标准
- •Patient age <18 years and >90 years
- •Patient not willing to participate at the follow-up
- •Pregnancy
- •retropatellar arthrosis requiring patella resurfacing
- •American Society of Anaesthesiologists (ASA) Classification >3
研究组 & 干预措施
OrthoPilot® Elite
navigated / computer assisted total knee replacement surgery
干预措施: Navigated total knee arthroplasty (Device)
MAKO
robot assisted total knee replacement surgery
干预措施: Robot assisted total knee arthroplasty (Device)
结局指标
主要结局
Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
时间窗: one year postoperatively
Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
次要结局
- Comparison of Radiographic status(one year postoperatively)
- Quality of Life [EQ-5D-5L](one year postoperatively)
- Anterior knee pain(one year postoperatively)
- Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)(one year postoperatively)
- (Serious) Adverse Events(During the course of the study up to one year postoperatively)
- Survival of the implant components(one year postoperatively)
- Comparison of Radiographic alignment(one year postoperatively)