ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- EQ-5D questionnaire
研究概览
简要总结
This is a prospective, single-center 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 Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.
详细描述
The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty.
The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; 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 70 Years（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
- •Pre-op component positioning and sizing plan prior to surgery
- •Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona 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 via ROSA Robot
干预措施: PERSONA Total Knee (Device)
Conventional TKA
Conventional TKA
干预措施: PERSONA Total Knee (Device)
结局指标
主要结局
EQ-5D questionnaire
时间窗: 1 year
EQ-5D
Oxford Knee Score Questionnaire
时间窗: 1 year
Oxford Knee Score
次要结局
未报告次要终点