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Playmaker 3D Printed Knee Extender

Primary Purpose

ACL, ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D printed knee extender device
Standard Prehabilitation Education
Sponsored by
Sanford Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL focused on measuring Desktop 3D Printing, Knee Extender, Pre-habilitation

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanford Orthopedics and Sports MedicineRecruiting
  • Sanford Orthopedics and Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Arm

Control Arm

Arm Description

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.

Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.

Outcomes

Primary Outcome Measures

Knee Extension Range of Motion
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.
Time to Achieve Full Knee Extension
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.

Secondary Outcome Measures

Knee Swelling
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.
Average Daily Pain Level
Participant average pain level for control and experimental groups is recorded in an at-home daily paper log and online surveys in RedCap, respectively.
Water Bottles Used with Knee Sling
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.
Minutes Spent Using Knee Sling
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.

Full Information

First Posted
March 28, 2023
Last Updated
May 18, 2023
Sponsor
Sanford Health
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1. Study Identification

Unique Protocol Identification Number
NCT05878652
Brief Title
Playmaker 3D Printed Knee Extender
Official Title
Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, ACL Injury
Keywords
Desktop 3D Printing, Knee Extender, Pre-habilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Other
Arm Description
Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
Intervention Type
Device
Intervention Name(s)
3D printed knee extender device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Prehabilitation Education
Intervention Description
Participants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
Primary Outcome Measure Information:
Title
Knee Extension Range of Motion
Description
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.
Time Frame
Change from baseline range of motion to day of ACL reconstruction.
Title
Time to Achieve Full Knee Extension
Description
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.
Time Frame
Through study completion, an average of 4 weeks.
Secondary Outcome Measure Information:
Title
Knee Swelling
Description
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.
Time Frame
Through study completion, an average of 4 weeks.
Title
Average Daily Pain Level
Description
Participant average pain level for control and experimental groups is recorded in an at-home daily paper log and online surveys in RedCap, respectively.
Time Frame
From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Title
Water Bottles Used with Knee Sling
Description
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.
Time Frame
From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Title
Minutes Spent Using Knee Sling
Description
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.
Time Frame
Through study completion, an average of 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Jensen
Phone
605-312-6983
Email
katie.e.jensen@sanfordhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Skelley, MD
Organizational Affiliation
Sanford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Orthopedics and Sports Medicine
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Mcevoy
Email
kathy.mcevoy@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Benjamin Noonan, MD
Facility Name
Sanford Orthopedics and Sports Medicine
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Adams
Email
luke.adams@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Nathan Skelley, MD

12. IPD Sharing Statement

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Playmaker 3D Printed Knee Extender

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