Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Early Recovery
研究概览
简要总结
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments.
MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.
详细描述
Research objectives:
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments
Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.
Secondary Hypothesis:
Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Planning to undergo Unilateral primary total knee arthroplasty
- •18 and up
- •Willing to sign informed consent
- •Willing to return for all follow-up visits
- •Smartphone or tablet device capable of running the Fitbit andFocusMotion platform
排除标准
- •BMI > 45
- •Inflammatory arthritis
- •Narcotic use greater than 5 days per week
- •Walking aid for musculoskeletal or neurologic issue other than operative joint
- •Bilateral total knee arthroplasty
- •Patient with an active infection or suspected infection in the operative joint
- •The absolute and relative contraindications stated in the FDA cleared labeling for the device
研究组 & 干预措施
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
干预措施: Device: Robotic MAKO total knee (Device)
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
干预措施: FocusMotion knee brace (Device)
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
干预措施: Fitbit tracking device (Device)
Prospective Group- Robotic TKA Arm
Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine
干预措施: FocusMotion app (Device)
Control- manual total Knee arthroplasty
Patients who have had a manual total knee arthroplasty
结局指标
主要结局
Early Recovery
时间窗: 1 week
To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score. VAS scale 0-10 (0= no pain, 10=extreme pain)
次要结局
- Post op EOS Measurements for Alignment(1 year)