NCT05878652

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

March 28, 2023

Last Update Submit

March 7, 2024

Conditions

ACLACL Injury

Keywords

Desktop 3D PrintingKnee ExtenderPre-habilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Knee Swelling

    Through study completion, an average of 4 weeks.

  • 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.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Device: 3D printed knee extender device

Control Arm

OTHER

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

Other: Standard Prehabilitation Education

Interventions

3D printed knee extender deviceDEVICE

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.

Experimental Arm
Standard Prehabilitation EducationOTHER

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

Control Arm

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old patients who have suffered an isolated primary ACL rupture

You may not qualify if:

  • Patients who have already attained full knee extension
  • Open skin wounds that would come into contact with the device
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanford Orthopedics and Sports Medicine

Fargo, North Dakota, 58103, United States

Location

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Nathan Skelley, MD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

May 26, 2023

Study Start

June 15, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

US(2)