The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:
• Age 18 and under
• Surgery within 6 months of injury
• Undergoing primary ACL reconstruction without previous injury or surgery
• Autograft ACL reconstruction
• Closing or closed physes
Locations
United States
Illinois
Lurie Children's Hospital
Recruiting
Chicago
Contact Information
Primary
Lauren Spirov, MS
lspirov@luriechildrens.org
312-227-8427
Backup
Neeraj Patel, MD
neepatel@luriechildrens.org
312-227-6190
Time Frame
Start Date: April 28, 2021
Estimated Completion Date: April 1, 2026
Participants
Target number of participants: 720
Treatments
Experimental: Concomitant ACL and ALL reconstruction
The participant will undergo both the ACL and ALL reconstruction surgery.
Experimental: ACL reconstruction alone
The participant will undergo only ACL reconstruction surgery.
Authors
Sponsors
Collaborators: Children's Hospital of Philadelphia, UCSF Benioff Children's Hospital - San Francisco, Texas Children's
Leads: Ann & Robert H Lurie Children's Hospital of Chicago