Clinical trial Recruiting at 1 site Interventional Ages Any age to 18

Evaluating ACL and ALL Reconstruction in Children

Official title: The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial

Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT04825587 · Data updated 2026-11-12

This study is testing if kids who have surgery for a knee ligament injury do better when they have two ligaments fixed instead of just one.

Quick facts

Study typeInterventional
AgesAny age to 18 Years
SexAll
Enrollment240 (estimated)
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
Academic / other
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedApril 28, 2021
Main results expectedApril 1, 2030
Study endsApril 1, 2030
Registry record updatedMay 29, 2026
Trial IDNCT04825587 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 18 and under who are undergoing primary ACL reconstruction within six months of their injury.

Probably not a fit

Patients over 18 years old or those with previous knee injuries or surgeries will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to assess whether the reconstruction of the anterolateral ligament (ALL) alongside the anterior cruciate ligament (ACL) in children undergoing surgery can reduce the rate of graft failure compared to ACL reconstruction alone. Given the rising incidence of ACL injuries in the pediatric population, this study seeks to address the higher risk of complications and re-injury faced by these young patients. Participants will be randomly assigned to receive either both ACL and ALL reconstruction or ACL reconstruction alone, with the goal of determining the long-term effectiveness of the combined approach.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of graft failure in children undergoing ACL reconstruction.

How similar studies have gone: While studies in adults have shown promise in reducing re-injury rates with concomitant ALL reconstruction, this specific approach in children is still being explored and is considered novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Lurie Children's Hospital
    Chicago, Illinois, United States
    Recruiting

Study contacts

  • Principal investigator: Neeraj Patel, MD — Ann & Robert H Lurie Children's Hospital of Chicago
  • Study coordinator: Amanda Kass
  • Email: akass@luriechildrens.org
  • Phone: 312-227-1267

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.