Anterior Cruciate Ligament InjuriesNCT06524349
Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
A study testing 3D printed knee extender device in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Tear, run by Sanford Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture
- What is being tested?
- 3D printed knee extender device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanford Orthopedics and Sports Medicine
Fargo, North Dakota, 58103
Sanford Orthopedics and Sports Medicine
Sioux Falls, South Dakota, 57104
About this study
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
- Being tested
- 3D printed knee extender device
- Keywords
- 3D printing, knee extender device
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3D printed knee extender device |
| Standard Rehabilitation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 6 weeks.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Jun 2024
- Primary completion4 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Skelley, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524349
- Sponsor's protocol ID
- SH AOSSM Grant Study
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
- ClinicalTrials.gov ID
- NCT06524349
- Acronym / sponsor ID
- SH AOSSM Grant Study
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture
- Keywords
- 3D printing, knee extender device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed knee extender device | Experimental | Device: 3D printed knee extender deviceParticipants 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. |
| Standard Rehabilitation | No intervention | – |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed knee extender deviceParticipants 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. | Device | 3D printed knee extender device |
Primary outcome
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.
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.
4 secondary outcomes
Knee Swelling
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Skelley, MD principal investigator
Sanford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed knee extender device in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Tear, run by Sanford Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Extension Range of Motion (time frame: Change from baseline range of motion to 6 week post-ACL surgery follow up visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.