A Single-arm, Monocentric, Cross-sectional, Pilot Study Evaluating Updated Features for The ROSA® Knee System, v1.5, in Patients Undergoing Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System
研究概览
简要总结
This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed.
The primary objectives will be assessed by measuring:
- Intra-operative complications
- Verification that the device performs as intended
- Overall surgeon satisfaction with the instrumentation.
详细描述
This study will involve single-arm, monocentric, cross-sectional observations conducted on the day of surgery. All assessments will take place during the pre-operative, intra-operative, and immediate postop periods on the day of surgery, with no additional follow-up beyond the procedure as robotic-assisted surgery using the current version of the robot is part of routine practice.
The safety of the system is the primary endpoint. This will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoint is defined by the usability of Zimmer Biomet ROSA® Knee System, v1.5. It will be assessed by:
- Robotic log files to assess differences in the proposed plans by the system's new features and plan approved by the surgeon, along with time spent in the planning panel.
- Surgeon satisfaction with the new features.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient is a minimum of 18 years of age
- •Independent of study participation, patient is a candidate for primary total knee arthroplasty using commercially available and compatible implants in accordance with product labeling
- •Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form
排除标准
- •Patient is currently participating in any other surgical intervention studies or pain management studies
- •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
Experimental: Zimmer Biomet ROSA® Knee System, v1.5
This study will include a single-arm of patients who qualify for robotic-assisted (RA) total knee arthroplasty (TKA) with the ROSA® Knee System and are planned to receive commercially available and compatible implants.
干预措施: Total Knee Arthroplasty (Device)
结局指标
主要结局
Incidence of Procedure-Emergent Adverse Events, to assess the Safety of the ROSA® Knee System v1.5 System
时间窗: Intra-operative observations, with immediate post-operative documentation and reporting period.
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. This will occur through the reporting of adverse events that outline the details and relationship to: 1. Device 2. Procedure 3. Instruments 4. Cement in order to determine device-related or non-device-related complications that occur during the procedure. Thus the incidence of procedure-emergent adverse events will notify and quantify the safety of the features added to the subject device (ROSA® Knee System v1.5 System)
次要结局
- Verification and Usability of the OptimiZe Planning and Activ Track Investigational Features of the ROSA® Knee System v1.5 System(Intra-operative evaluation, with immediate post-operative assessment and documentation. Data and statistical analysis will take place after the recruitment period has concluded.)