Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measured Balance Value of the Medial Side of Knee during TKA
研究概览
简要总结
The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Surgical candidates undergoing primary TKA
排除标准
- •Patient is unable to provide written consent
研究组 & 干预措施
TKA Patients
TKA patients will undergo total knee replacement as part of standard of care. The 3D printed mechanical balancer will be used at one timepoint during surgery while the patient is under anesthesia during their scheduled TKA surgery.
干预措施: 3D-Printed Mechanical Balancer (Device)
结局指标
主要结局
Measured Balance Value of the Medial Side of Knee during TKA
时间窗: Day 1 (During TKA Procedure)
Measured using the 3D-printed mechanical knee balancer.
Measured Balance Value of the Lateral Side of Knee during TKA
时间窗: Day 1 (During TKA Procedure)
Measured using the 3D-printed mechanical knee balancer.
次要结局
- Range of Motion at Pre-Operative Visit(Baseline)
- Range of Motion at Post-Operative Visit(Up to Year 2 Post-Procedure)
- Cases of Revision Surgery(Up to Year 2)