Playmaker 3D Printed Knee Extender

Not Applicable

Terminated

• Conditions: ACL; ACL Injury
• Interventions: Other: Standard Prehabilitation Education; Device: 3D printed knee extender device

• Registration Number: NCT05878652
• Lead Sponsor: Sanford Health

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average Daily Pain Level	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.
Water Bottles Used with Knee Sling	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.
Minutes Spent Using Knee Sling	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.
Knee Swelling	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.

Trial Locations

Locations (1)

Sanford Orthopedics and Sports Medicine; 🇺🇸 Sioux Falls, South Dakota, United States