Playmaker 3D Printed Knee Extender

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05878652
• Other study ID #: Playmaker
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Device:
• 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.

Other:
• Standard Prehabilitation Education
Participants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home.

Locations

Country	Name	City	State
United States	Sanford Orthopedics and Sports Medicine	Fargo	North Dakota
United States	Sanford Orthopedics and Sports Medicine	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline range of motion to day of ACL reconstruction.
Primary	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.	Through study completion, an average of 4 weeks.
Secondary	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.	Through study completion, an average of 4 weeks.
Secondary	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.	From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Secondary	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.	From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Secondary	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.	Through study completion, an average of 4 weeks.