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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Knee Extension Range of Motion

Time to Achieve Full Knee Extension

Secondary outcome measures

Average Daily Pain Level

Knee Swelling

Minutes Spent Using Knee Sling

+1 more

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

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor

48 Previous Clinical Trials

61,887 Total Patients Enrolled

Nathan Skelley, MDPrincipal InvestigatorSanford Health

Media Library

Experimental Arm Clinical Trial Eligibility Overview. Trial Name: NCT05878652 — N/A

Anterior Cruciate Ligament (ACL) Research Study Groups: Experimental Arm, Control Arm

Anterior Cruciate Ligament (ACL) Clinical Trial 2023: Experimental Arm Highlights & Side Effects. Trial Name: NCT05878652 — N/A

Experimental Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can potentially take part in this experiment?

"Affirmative. Per the data recorded on clinicaltrials.gov, this medical trial is still looking for participants, with 36 individuals sought between 2 sites. The initial post date was June 15th 2022 and it has been most recently modified on May 18th 2023."

Answered by AI

What are the eligibility criteria for individuals to participate in this experiment?

"To be considered for the trial, applicants must possess a pre-existing anterior cruciate ligament (ACL) and fall within the age bracket of 14 to 60. A total of 36 participants are necessary."

Answered by AI

Is this trial currently open to new participants?

"As confirmed on clinicaltrials.gov, this research project is currently looking for volunteers and was initially launched on June 15th 2022; the details were most recently updated on May 18th 2023."

Answered by AI

Is the age restriction for this research set at 35 and under?

"Eligibility criteria for this medical research demands that participants are aged between 14 and 60. However, there are 52 studies available to those younger than 18 years old, as well as 27 specifically designed for individuals 65 or older."

Answered by AI

What is the desired outcome of this research endeavor?

"This clinical trial is designed to measure the time it takes for full knee extension from baseline range of motion. Secondary objectives include tracking participants' average daily pain levels, number of water bottles used with their knee slings, and amount of minutes spent using a knee sling in prehab sessions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Playmaker 3D Printed Knee Extender

2022. "Playmaker 3D Printed Knee Extender". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878652.

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