Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
Purpose
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
Eligibility
- Eligible Ages
- Between 14 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
- Masking Description
- Study team member who obtains knee measurements will be blinded to study treatment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
No Intervention Standard Rehabilitation |
|
Recruiting Locations
Sanford Orthopedics and Sports Medicine
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Sanford Orthopedics and Sports Medicine
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
More Details
- NCT ID
- NCT06524349
- Status
- Recruiting
- Sponsor
- Sanford Health