Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software
研究概览
简要总结
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.
Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
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
- •Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis
- •Written signed informed consent of patient
- •Willingness and mental ability to participate at the long-term follow-up examinations
排除标准
- •Pregnancy
- •Patients < 18 years or > 80 years
- •Patients unable to participate at the follow-up examination (physically, mentally)
- •Previous joint replacement at the index knee
- •ASA classification > 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)
结局指标
主要结局
Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software
时间窗: 3 months post OP
The primary variable delta (aHKA), is defined as the difference in the arithmetic hip-knee-angle (aHKA) between the 3 months postoperative and the intraoperatively planned value. The aHKA is calculated as the difference of the mechanical medial proximal tibial angle (MPTA) and the mechanical lateral distal femoral angle (LDFA), both measured in degrees.
次要结局
- Implant survival(ongoing, up to 2 years follow-up)
- Oxford Knee Score (OKS)(Preoperative,3 months-, 12 months and 2 years post operative)
- Forgotten Joint Score (FJS)(Preoperative,3 months-, 12 months and 2 years post operative)
- Quality of Life (EQ-5D-5L)(Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months)
- NET Promotor Score (NPS)(Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months)
- Anterior knee pain(Preoperative,3 months-, 12 months and 2 years post operative)
- Radiological results(Preoperative, Discharge, 1 year post op)
- All (Serious) Adverse Events(2 years)