Clinical Trials Directory

Trials / Terminated

TerminatedNCT05878652

Playmaker 3D Printed Knee Extender

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Sanford Health · Academic / Other
Sex
All
Age
14 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICE3D printed knee extender deviceParticipants 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.
OTHERStandard Prehabilitation EducationParticipants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home.

Timeline

Start date
2022-06-15
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2023-05-26
Last updated
2024-03-08

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05878652. Inclusion in this directory is not an endorsement.