STaR Study for Multiple Ligament Knee Injuries (MLKI)

Purpose of this Study

We are doing this study to figure out the best approaches for treating knee injuries that involve more than one ligament. There are 2 primary goals of this study. In Aim 1 of the study, we want to find out if it is better to have surgery shortly after MLKI or if it is better to delay surgery. In Aim 2 of the study, we want to find out if it is better to start physical rehabilitation shortly after surgery or if it is better to delay rehabilitation for a few weeks.

Who Can Participate?

Eligibility

Adults and children ages 16-55 who:
  • Have an MLKI (grade III injury of 2 or more knee ligaments)
  • Plan to have surgery to treat their injury
  • Have not had a previous ligament reconstruction surgery on the injured knee
People who are not eligible for Aim 1 because it is not possible or feasible to delay their planned surgery may still be eligible to participate in Aim 2. For more information about who can join this study, please contact the study team at cassandra.rhodes@duke.edu.

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, the timing of your knee surgery and your rehabilitation after surgery will be determined by random chance (like a coin toss). Participating in this study will only affect when you have surgery and when you start physical rehabilitation. The type of surgery you have is up to you and your doctor. Your rehabilitation strategy will be tailored to the type of surgery you and your doctor choose. We will also ask you to fill out some questionnaires to update us on your recovery after surgery. You will fill out these questionnaires either online or during your regular follow-up visits after surgery. The approximate times you will fill out these questionnaires are:
  • 1 week after surgery
  • 1 month after surgery
  • 3 months after surgery
  • 6 months after surgery
  • Every month after the 6th month following surgery until the 24-month mark

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial

Principal Investigator

Jonathan
Dickens

Protocol Number

PRO00110945

NCT ID

NCT03543098

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov