Observation of Wheeled Device Use After TKA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Mobility after surgery
研究概览
简要总结
Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool.
详细描述
Individuals living with challenges that affect their mobility may lead to loss of independence, loss of activity and engagement with life. We are seeking individuals who are having a Total Knee Replacement and are seeking increased mobility using the Alinker, which is a non-motorized walking bike without pedals.
Each participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any person receiving Primary Total Knee Arthroplasty, ages 18-99
- •Patient is mobile with no more than a single cane/single crutch assist preoperatively
排除标准
- •Any person not receiving knee arthroplasty, ages under 18 or greater than 99
- •Patient requires simultaneous or staged bilateral replacements, staged <90 days apart.
- •Patients who have active claudication from a lumbar stenosis or peripheral vascular disease
研究组 & 干预措施
1
19 patients get an A-linker 1-3 months before surgery (knee arthroplasty)
干预措施: Mobility Tool (Device)
结局指标
主要结局
Mobility after surgery
时间窗: 6 months
Mobility will be assessed by using a bicycle odometer to track usage and mobility. The odometer will be checked 2 weeks, 6 weeks, and 3 months after surgery during a post-op clinical exam.
次要结局
- Change in knee society score(6 months)
- surgery cancellation(6 months)
- Use of gait aide(6 months)
- Determining intensity of pain(6 months)
- Time with Device(6 months)
研究者
Derek Amanatullah
Associate Professor of Orthopaedic Surgery
Stanford University