Playmaker 3D Printed Knee Extender

NCT ID: NCT05878652

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-12-31

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.

Conditions

ACL; ACL Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

3D printed knee extender device

Intervention Type: 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.

Control Arm

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

Group Type: OTHER

Standard Prehabilitation Education

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard Prehabilitation Education

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanford Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Skelley, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Health

Locations

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, United States

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, United States

Countries

United States

Other Identifiers

Playmaker

Identifier Type: -

Identifier Source: org_study_id