Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery

Sanford Health45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Rupture

Interventions

3D printed knee extender deviceDEVICE

Participants will receive a 3D printed knee extender device with sealed water bottles and an at-home rehabilitation program designed to be used with the 3D printed knee extender device.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Non-English speaking

Locations (2)

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, United States

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, an average of 6 weeks.

Secondary Outcomes

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.

Time frame: 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.

Time frame: From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.

Water bottles used with knee extender device

Data from ClinicalTrials.gov

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