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

Sanford Health

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture

Treatments: Device: 3D printed knee extender device

Study type: Interventional

Funder types: Other

Identifiers

NCT06524349

SH AOSSM Grant Study

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

3D printed knee extender device

Experimental group

Description:

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.

Treatment:

Device: 3D printed knee extender device

Standard Rehabilitation

No Intervention group