Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
NCT Number: NCT06524349
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cruciate Ligament Injuries|Anterior Cruciate Ligament Tear|Anterior Cruciate Ligament Rupture
Interventions: DEVICE: 3D printed knee extender device
Sponsor: Sanford Health
Sex: ALL
Age: CHILD, ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-06-07
Locations: Sanford Orthopedics and Sports Medicine, Fargo, North Dakota, 58103, United States|Sanford Orthopedics and Sports Medicine, Sioux Falls, South Dakota, 57104, United States

Summary:
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.

Primary Outcome Measures: Knee Extension Range of Motion, 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., Change from baseline range of motion to 6 week post-ACL surgery follow up visit.|Time to Achieve Full Knee Extension, 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., Through study completion, an average of 6 weeks.
Secondary Outcome Measures: Knee Swelling, Participants knee swelling is measured by a trained study member who is blinded to the participant's study group. Circumference of the knee is used as a proxy for knee swelling, and is measured by wrapping a tape measure around the circumference of the knee just proximal to the superior pole of the patella with resting tension., through study completion, an average of 6 weeks.|Average Daily Pain Level, Participants will complete a weekly follow up survey which will ask them about their average pain level., From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.|Water bottles used with knee extender device, Participant in the experimental arm will provide the average number of water bottles used to weigh down their knee sling during their weekly follow up survey., From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.|Minutes Spent Using Knee Extender Device, Participants in the experimental arm will provide the average number of minutes spend using their knee extender device during their weekly follow up survey, From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.