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

August 11, 2025 updated by: Sanford Health
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Sanford Orthopedics and Sports Medicine
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Orthopedics and Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printed knee extender device
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
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.
No Intervention: Standard Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline range of motion to 6 week post-ACL surgery follow up visit.
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.
Through study completion, an average of 6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 6 weeks.
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.
From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
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.
From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
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
From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Nathan Skelley, MD, Sanford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2024

Primary Completion (Actual)

June 4, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH AOSSM Grant Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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