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Playmaker 3D Printed Knee Extender

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Sanford Health

Status

Terminated

Conditions

ACL
ACL Injury

Treatments

Other: Standard Prehabilitation Education
Device: 3D printed knee extender device

Study type

Interventional

Funder types

Other

Identifiers

NCT05878652
Playmaker

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

14 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups

Experimental Arm
Experimental group
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.
Treatment:
Device: 3D printed knee extender device
Control Arm
Other group
Description:
Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
Treatment:
Other: Standard Prehabilitation Education

Trial contacts and locations

2

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Central trial contact

Katie Jensen

Data sourced from clinicaltrials.gov

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