Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Knee Extension Range of Motion
研究概览
简要总结
The purpose of this study is to explore patient outcomes associated with, the use of a 3D printed knee extender device, in conjunction with an at-home rehabilitation program, for patients who are performing knee rehabilitation after anterior cruciate ligament (ACL) surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Study team member who obtains knee measurements will be blinded to study treatment.
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a primary ACL rupture. Secondary knee pathology such as, but not limited to bone edema, strains, and meniscal pathology are acceptable as long as the primary injury and indication for surgery is the ACL rupture.
- •Able and willing to adhere to the study procedures
- •Able to consent for self-, or able to assent for self with parental consent
排除标准
- •Pregnancy
- •Non-English speaking
研究组 & 干预措施
3D printed knee extender device
Participants will utilize a 3D printed knee extender device and an at-home home rehabilitation program designed to be used with the 3D printed knee extender device.
干预措施: 3D printed knee extender device (Device)
Standard Rehabilitation
结局指标
主要结局
Knee Extension Range of Motion
时间窗: Change from baseline range of motion to 6 week post-ACL surgery follow up visit.
Knee extension range of motion is measured by a trained study member who is blinded to the participant's study group using a goniometer. Participants are seated on the exam table with their leg maximally extended. The center of the goniometer is placed over the lateral epicondyle of the affected knee. One of the goniometer arms is aimed proximally, pointing toward the greater trochanter of the hip. The other arm is aimed distally, pointing toward the lateral malleolus of the ankle. The study member then reads the angle created by the arms of the goniometer in this position.
Time to Achieve Full Knee Extension
时间窗: Through study completion, an average of 6 weeks.
Full knee extension will be measured at home by participants by placing a clicking device under their knee which will produce an audible "click" when the knee is fully extended, and the clicker is depressed. Participants in the control and experimental groups will notify the study team during weekly follow up surveys whether they are able to depress the clicker or not.
次要结局
- Minutes Spent Using Knee Extender Device(From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.)
- Water bottles used with knee extender device(From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.)
- Knee Swelling(through study completion, an average of 6 weeks.)
- Average Daily Pain Level(From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.)