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

NCT ID: NCT06524349

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
Study team member who obtains knee measurements will be blinded to study treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

3D printed knee extender device

Intervention Type 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.

Standard Rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanford Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Skelley, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Health

Locations

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Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, United States

Site Status

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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SH AOSSM Grant Study

Identifier Type: -

Identifier Source: org_study_id

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