Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ACL
- Sponsor
- Sanford Health
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Time to Achieve Full Knee Extension
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Time to Achieve Full Knee Extension
Time Frame: 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
Time Frame: 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 Outcomes
- Average Daily Pain Level(From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.)
- Water Bottles Used with Knee Sling(From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.)
- Minutes Spent Using Knee Sling(Through study completion, an average of 4 weeks.)
- Knee Swelling(Through study completion, an average of 4 weeks.)