Playmaker 3D Printed Knee Extender

March 7, 2024 updated by: Sanford Health

Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries

The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Sanford Orthopedics and Sports Medicine
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Orthopedics and Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 14-60 years old patients who have suffered an isolated primary ACL rupture

Exclusion Criteria:

  • Patients who have already attained full knee extension
  • Open skin wounds that would come into contact with the device
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
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.
Device: 3D printed knee extender device
Participants will receive the standard of prehabilitation education at Sanford as well as a 3D printed knee extension device with sealed water bottles and a home prehabilitation program designed to be used with the 3D printed knee extension device.
Other: Control Arm
Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
Other: Standard Prehabilitation Education
Participants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Extension Range of Motion
Time Frame: Change from baseline range of motion to day of ACL reconstruction.
Knee extension range of motion is measured by a trained study member who is blinded to the participant's study group using a goniometer in clinic. Participants are seated on the exam table with their leg maximally extended. The center of the goniometer is placed over the lateral epicondyle of the affected knee. One of the goniometer arms is aimed proximally, pointing toward the greater trochanter of the hip. The other arm is aimed distally, pointing toward the lateral malleolus of the ankle. The study member then reads the angle created by the arms of the goniometer in this position.
Change from baseline range of motion to day of ACL reconstruction.
Time to Achieve Full Knee Extension
Time Frame: Through study completion, an average of 4 weeks.
Full knee extension will be measured at home by participants by placing a clicking device under their knee which will produce an audible "click" when the knee is fully extended, and the clicker is depressed. Participants in the control and experimental groups record whether they are able to depress the clicker in at-home logs daily paper logs and online surveys in RedCap, respectively.
Through study completion, an average of 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Swelling
Time Frame: Through study completion, an average of 4 weeks.
Participant knee swelling is measured by a trained study member who is blinded to the participant's study group in clinic. Circumference of the knee is used as a proxy for knee swelling, and is measured by wrapping a tape measure around the circumference of the knee just proximal to the superior pole of the patella with resting tension.
Through study completion, an average of 4 weeks.
Average Daily Pain Level
Time Frame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Participant average pain level for control and experimental groups is recorded in an at-home daily paper log and online surveys in RedCap, respectively.
From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Water Bottles Used with Knee Sling
Time Frame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Participants in the experimental group record how many water bottles they use to weigh down their knee sling, up to a maximum of ten water bottles, in online surveys in RedCap in each of the morning, afternoon, and evening prehab sessions.
From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Minutes Spent Using Knee Sling
Time Frame: Through study completion, an average of 4 weeks.
Participants in the experimental group record how many minutes they spend using the knee sling, up to a maximum of ten minutes, in online surveys in RedCap in each of the morning, afternoon, and evening prehab sessions.
Through study completion, an average of 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Nathan Skelley, MD, Sanford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Playmaker

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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