oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aesculap AG
- 入组人数
- 1,020
- 主要终点
- Safety of the implant
研究概览
简要总结
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
详细描述
Safety and Clinical Performance will be observed:
Safety: All adverse device effects: serious and non-serious adverse events with relation to either the product or the surgical procedure.
Clinical Performance: Difference in Oxford Knee Score (OKS) 2 years after implantation compared to preoperative state.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≤ 80 years
- •Indication for a total knee replacement with one of the variants
- •Written informed consent
- •Willingness and mental ability to participate at the long-term follow-up examinations
排除标准
- •Contraindications acc. to the Instructions for Use (IFU)
- •Patient age < 18 years
- •Known pregnancy
- •BMI > 40
- •Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)
- •Patients classified as high risk (ASA class >3)
- •Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
- •Preoperative: aHKA > 190° or aHKA < 170°
- •Preoperative: aHKA > 190° or aHKA < 170°[KB1.1][HO1.2][KB1.3][HO1.4]
- •Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator
结局指标
主要结局
Safety of the implant
时间窗: 2 years after implantation
Safety in terms of clinical outcome of oneKNEE® All adverse device effects: serious and non-serious adverse events with relation to either the product or the surgical procedure.
Clinical Performance in terms of clinical outcome of oneKNEE®
时间窗: 2 years after implantation
Clinical Performance in terms of clinical outcome of oneKNEE®. Difference in Oxford Knee Score (OKS) 2 years after implantation compared to preoperative state. The Oxford Knee Score (OKS) is a validated joint-specific patient-reported outcome measure that is commonly employed to assess the outcome of TKA. It is a 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing TKA. It is short, reproducible, valid and sensitive to clinically important changes over time. OKS ranges from 0 to 48 with 48 being the best outcome.
次要结局
- Clinical Outcome by evaluating the Oxford Knee Score(V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years p.OP, V8= 7years p.OP, V9=10 years p.OP, V10=15 y. p.OP)
- Evaluation of Changes in Quality of Life(V1= pre OP, V3= Discharge, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Evaluation of Patient Satisfaction by using PROMS: FJS(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Knee functional outcome(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Knee alignment, measurement of LDFA: Lateral distal femoral angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Knee alignment, measurement of MPTA: Medial proximal tibial angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Knee alignment, measurement of HKA: Hip Knee Angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Radiologically relevant findings by using AI(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP, V8= 7 years post OP, V9= 10 years post OP, V10= 15 years post OP)
- Adverse events(15 years)
- Device deficiencies assessed by Adverse Events(15 years)
- Intraoperative complications(day of surgery)
- Survival of implant components(From V3=Discharge to V10 = 15 years post OP)
- Optional: OrthoPilot® Data(Day of surgery)
- Clinical Outcome by evaluating the Oxford Knee Score(V4=3 months post OP, V5= 1year p.OP, V6= 2years p.OP, V7= 5years p.OP)
- Evaluation of Changes in Quality of Life(V1= pre OP, V3= Discharge, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP,)
- Evaluation of Patient Satisfaction by using PROMS: FJS(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Knee functional outcome(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Knee alignment, measurement of LDFA: Lateral distal femoral angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Knee alignment, measurement of MPTA: Medial proximal tibial angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Knee alignment, measurement of HKA: Hip Knee Angle(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Radiologically relevant findings by using AI(V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP)
- Adverse events(until end of study, up to 5 years.)
- Device deficiencies assessed by Adverse Events(until end of study, up to 5 years)
- Survival of implant components(From V3=Discharge to V7= 5 years post OP)
- Anterior knee pain(V1= preoperatively, V4= 3 months post OP, V5= 1 year post OP, V6= 2 years post OP, V7= 5 years post OP,)