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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 weeks. for reporting.

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 more

Awards & 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.

Do I qualify?Apply below to find out