ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 5
- 主要终点
- Post-Operative Pain & Satisfaction
研究概览
简要总结
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
详细描述
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
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
- 是
入选标准
- •Patient is a minimum of 18 years of age
- •Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and 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 IRB or EC approved Informed Consent form
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations
排除标准
- •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 contracture, 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
Robotic Assisted TKA
Robotic Assisted TKA
干预措施: PERSONA Total Knee (Device)
Robotic Assisted TKA
Robotic Assisted TKA
干预措施: Vanguard Total Knee (Device)
Robotic Assisted TKA
Robotic Assisted TKA
干预措施: NexGen Total Knee (Device)
Conventional TKA
Conventional TKA
干预措施: PERSONA Total Knee (Device)
Conventional TKA
Conventional TKA
干预措施: Vanguard Total Knee (Device)
Conventional TKA
Conventional TKA
干预措施: NexGen Total Knee (Device)
结局指标
主要结局
Post-Operative Pain & Satisfaction
时间窗: 6 weeks, 3 months, and 1 year
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Clinical Performance
时间窗: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Total Range of Motion
时间窗: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Oxford
时间窗: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
次要结局
未报告次要终点