Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 217
- 试验地点
- 3
- 主要终点
- Rate of Lower Limb Alignment inside the range of 0±3°
研究概览
简要总结
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
详细描述
The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation >3° from neutral alignment is defined as an outlier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
- •Dated and signed informed consent
- •Exclusion: Exclusion Criteria
- •Pregnancy
- •Patients < 18 years
- •Patients unable to participate at the follow-up examination (physically, mentally)
- •Previous joint replacement at the indexed knee
排除标准
- 未提供
结局指标
主要结局
Rate of Lower Limb Alignment inside the range of 0±3°
时间窗: three months postoperatively
A postoperative lower limb alignment of the knee prosthesis in reference to the mechanical leg axis (3, 18) outside the range of ± 3° is defined as the outlier. The outlier rates will be used as the efficacy criterion for groups comparison
次要结局
- Learning Curve(Intraoperatively)
- Intraoperative handling of soft- and hardware components(Intraoperatively)
- Lower limb alignment of the knee prosthesis in reference to the mechanical leg axis(3 months postoperatively)
- Improvement of Knee Society Score (KSS)(preoperatively and three months postoperatively)
- Improvement of Oxford Knee Score (OKS)(preoperatively and three months postoperatively)
- Improvement of Quality of Life (EQ-5D-5L)(preoperatively and three months postoperatively)
- (Serious) Adverse Device Effects(up to 3 months postoperatively)