Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Patient reported Questionnaires for weekly VAS pain scores up weekly
研究概览
简要总结
To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.
详细描述
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System
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
- •A. Unilateral primary medial unicompartmental knee arthroplasty
- •B. Age 18 years of age or older
- •C. Willing to sign informed consent
- •D. Willing to return for all follow-up visits
- •E. Smartphone or tablet device capable of running the FocusMotion platform
排除标准
- •A. BMI > 40
- •B. Personal history of DVT or PE
- •C. Inflammatory arthritis
- •D. Peripheral vascular disease
- •E. Opioid use greater than 5 days per week
- •F. Nonsteroidal anti-inflammatory allergy
- •G. Walking aid for musculoskeletal or neurologic issue other than operative joint
- •H. Bilateral medial unicompartmental knee arthroplasty
- •I. Patient with an active infection or suspected infection in the operative joint
- •J. The absolute and relative contraindications stated in the FDA cleared labeling for the device
研究组 & 干预措施
UKA MAKO
Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey
干预措施: focus motion knee brace (Device)
TKA MAKO
Control group-Already collected data on patient reported out comes using the FocusMotion app survey
干预措施: focus motion knee brace (Device)
结局指标
主要结局
Patient reported Questionnaires for weekly VAS pain scores up weekly
时间窗: 1 year
Patients will assess their weekly pain scores by filling out patient reported outcomes.
次要结局
- Patient will track their Opioid Consumption use by filling out a chart weekly(3 months)