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3D Printed Knee Extender for ACL Injury
N/A
Waitlist Available
Led By Nathan Skelley, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial explores how a custom-made knee extender and video-based home pre-hab program can help ACL-rupture patients before surgery.
Who is the study for?
This trial is for individuals aged 14-60 who have experienced an isolated primary ACL rupture. It's designed to help those preparing for surgery with a new tool and educational program.
What is being tested?
The study tests a personalized 3D printed knee extender device alongside standard prehabilitation education, aiming to improve outcomes before ACL surgery.
What are the potential side effects?
Since the intervention includes a physical device and educational materials, there are no direct medical side effects; however, discomfort or skin irritation from the device may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Knee Extension Range of Motion
Time to Achieve Full Knee Extension
Secondary study objectives
Average Daily Pain Level
Knee Swelling
Minutes Spent Using Knee Sling
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Participants will utilize a 3D printed knee extension device and an at-home prehabilitation program designed to be used with the 3D printed knee extension device.
Group II: Control ArmExperimental Treatment1 Intervention
Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
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Who is running the clinical trial?
Sanford HealthLead Sponsor
50 Previous Clinical Trials
66,915 Total Patients Enrolled
Nathan Skelley, MDPrincipal InvestigatorSanford Health
1 Previous Clinical Trials
28 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 14 and 60 years old and have had an ACL tear with no other injuries.I can fully straighten my knee.I have open skin wounds that the medical device would touch.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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