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

NCT06524349 | Active Not Recruiting

• 1 other identifier: SH AOSSM Grant Study
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

3D printing; knee extender device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

• Water bottles used with knee extender device

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

• Minutes Spent Using Knee Extender Device

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

Study Arms (2)

3D printed knee extender device

EXPERIMENTAL

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.

Device: 3D printed knee extender device

Standard Rehabilitation

NO INTERVENTION

Interventions

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.

3D printed knee extender device

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Non-English speaking

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (2)

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, 58103, United States

Location

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Nathan Skelley, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Study team member who obtains knee measurements will be blinded to study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: June 7, 2024
• Primary Completion: June 4, 2025
• Study Completion: December 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (2)