Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Time to Achieve Full Knee Extension
研究概览
简要总结
The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.
详细描述
The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •14-60 years old patients who have suffered an isolated primary ACL rupture
排除标准
- •Patients who have already attained full knee extension
- •Open skin wounds that would come into contact with the device
- •Pregnant women
研究组 & 干预措施
Experimental Arm
Participants will utilize a 3D printed knee extension device and an at-home prehabilitation program designed to be used with the 3D printed knee extension device.
干预措施: 3D printed knee extender device (Device)
Control Arm
Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
干预措施: Standard Prehabilitation Education (Other)
结局指标
主要结局
Time to Achieve Full Knee Extension
时间窗: Through study completion, an average of 4 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 record whether they are able to depress the clicker in at-home logs daily paper logs and online surveys in RedCap, respectively.
Knee Extension Range of Motion
时间窗: Change from baseline range of motion to day of ACL reconstruction.
Knee extension range of motion is measured by a trained study member who is blinded to the participant's study group using a goniometer in clinic. 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.
次要结局
- Average Daily Pain Level(From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.)
- Water Bottles Used with Knee Sling(From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.)
- Minutes Spent Using Knee Sling(Through study completion, an average of 4 weeks.)
- Knee Swelling(Through study completion, an average of 4 weeks.)