The Pediatric ALL Evaluation and Trial for ACL Injuries

This study is looking at ways to improve knee surgery for children and teenagers who have torn their anterior cruciate ligament (ACL). Researchers want to see if adding a reconstruction of another ligament, called the anterolateral ligament (ALL), at the same time as ACL reconstruction will lead to fewer problems with the ACL graft failing later on. You could be eligible if you are 18 or younger, need your first ACL surgery within 6 months of injury, and meet other specific criteria. The study aims to enroll 240 participants and will track how well the graft works for up to 5 years after surgery.

Study design
This is an interventional study where participants will be randomly assigned to one of two groups: either receiving both ACL and ALL reconstruction, or ACL reconstruction alone. The study plans to enroll 240 participants.
What's involved
Participants will receive either concomitant ACL and ALL reconstruction or ACL reconstruction alone. They will then be followed for data collection for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for data collection for up to 5 years after their intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04825587

The Pediatric ALL Evaluation and Trial

Recruiting
NAUp to 18InterventionalTreatment
Ann & Robert H Lurie Children's Hospital of Chicago
~240 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft failure
Measured over Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
ACL Injury
ACL Tear

NCT04825587

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Lurie Children's Hospital

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Neeraj Patel, MD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

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Eligibility criteria

Inclusion

Age 18 and under
Surgery within 6 months of injury
Undergoing primary ACL reconstruction without previous injury or surgery
Quadriceps tendon autograft ACL reconstruction
Closing or closed physes

Exclusion

Over 18 years old
Previous ipsilateral knee injury or surgery
Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control
Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC)
Revision ACL reconstruction
ACL reconstruction with graft other than quadriceps tendon
IT band (modified MacIntosh) ACL reconstruction
A cartilage lesion requiring anything more than debridement
Open physes requiring both femoral and tibial physeal-sparing technique
  • Graft failureComplete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.

    To determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure (confirmed graft re-tear or asymmetric, increased pivot shift) than ACL reconstruction alone.