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NCT Number: NCT06524349

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanford Orthopedics and Sports Medicine, Fargo, North Dakota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D printed knee extender device

Device

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.

Primary outcomes

  1. Knee Extension Range of Motion

    Time frame: 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.

  2. Time to Achieve Full Knee Extension

    Time frame: 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.

Secondary outcomes

  1. Knee Swelling

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

    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.

  2. Average Daily Pain Level

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

    Participants will complete a weekly follow up survey which will ask them about their average pain level.

  3. Water bottles used with knee extender device

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

    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.

  4. Minutes Spent Using Knee Extender Device

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

    Participants in the experimental arm will provide the average number of minutes spend using their knee extender device during their weekly follow up survey

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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