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3D Printed Knee Extender for ACL Injury

N/A
Recruiting
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 from baseline until their 6-week post-acl surgery follow up visit, an average of 6 weeks.
Awards & highlights

Summary

This trial aims to see how well a 3D printed knee extender device, along with at-home rehabilitation exercises, helps patients recovering from ACL surgery.

Who is the study for?
This trial is for individuals recovering from ACL surgery. Participants should be following a home rehabilitation program and willing to use a new 3D printed knee extender device designed to aid in their recovery.
What is being tested?
The study tests the effectiveness of a custom-made 3D printed knee extender used alongside an at-home rehab plan, aiming to improve outcomes for patients after ACL surgery.
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where the device contacts the leg, increased soreness due to its usage, or an allergic reaction to materials in the extender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until their 6-week post-acl surgery follow up visit, an average of 6 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until their 6-week post-acl surgery follow up visit, an average of 6 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 Extender Device
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 3D printed knee extender deviceExperimental Treatment1 Intervention
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 II: Standard RehabilitationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
49 Previous Clinical Trials
61,923 Total Patients Enrolled
Nathan Skelley, MDPrincipal InvestigatorSanford Health
1 Previous Clinical Trials
36 Total Patients Enrolled
~9 spots leftby Dec 2024
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