ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 6
- 主要终点
- Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation
研究概览
简要总结
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.
详细描述
The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters.
The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- 未提供
排除标准
- •Inclusion criteria:
- •Patient is a minimum of 18 years of age
- •Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or Vanguard knee components implanted in accordance with product labeling
- •Patient has participated in this study-related Informed Consent Process
- •Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- •Exclusion criteria:
- •Patient is currently participating in any other surgical intervention studies or pain management studies
- •Patient has underwent contralateral UKA or TKA within the last 18 months
- •Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
- •Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation)
- •Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- •Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
研究组 & 干预措施
Conventional TKA Instrumentation
Total knee arthroplasty performed with conventional instrumentation
干预措施: Device: Vanguard Total Knee (Procedure)
ROSA Total Knee Robotic Instrumentation
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
干预措施: Device: Persona Total Knee (Procedure)
ROSA Total Knee Robotic Instrumentation
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
干预措施: Device: NexGen Total Knee (Procedure)
ROSA Total Knee Robotic Instrumentation
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
干预措施: Device: Vanguard Total Knee (Procedure)
Conventional TKA Instrumentation
Total knee arthroplasty performed with conventional instrumentation
干预措施: Device: Persona Total Knee (Procedure)
Conventional TKA Instrumentation
Total knee arthroplasty performed with conventional instrumentation
干预措施: Device: NexGen Total Knee (Procedure)
结局指标
主要结局
Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation
时间窗: 1 year
measuring femoral rotation in the axial plane using pre and post op CT assessments
次要结局
- Measure operative workflow efficiency by recording following time points during surgery(1 year)
- Evaluate Health related quality of life at baseline and each post-operative follow up(1 year)
- Evaluate knee functionality at baseline and each post-operative follow up(1 year)
- Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up(1 year)
- Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up(1 year)
- Evaluate Pain intensity at baseline and each post-operative follow up(1 year)
- Evaluate awareness of patients affected knee joint at baseline and each post operative follow up(1 year)