← Back to Clinical Trials
Recruiting NCT04825587

NCT04825587 The Pediatric ALL Evaluation and Trial

◆ AI Clinical Summary
Plain-language summary for patients
Clinical Trial Summary
NCT ID NCT04825587
Status Recruiting
Phase
Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Condition ACL Injury
Study Type INTERVENTIONAL
Enrollment 240 participants
Start Date 2021-04-28
Primary Completion 2030-04-01

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 240 participants in total. It began in 2021-04-28 with a primary completion date of 2030-04-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Amanda Kass

✉ akass@luriechildrens.org

📞 312-227-1267

Principal Investigator

Neeraj Patel, MD

PRINCIPAL INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Frequently Asked Questions

Who can join the NCT04825587 clinical trial?

This trial is open to participants of all sexes, up to 18 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04825587 currently recruiting?

Yes, NCT04825587 is actively recruiting participants. Contact the research team at akass@luriechildrens.org for enrollment information.

Where is the NCT04825587 trial being conducted?

This trial is being conducted at Chicago, United States.

Who is sponsoring the NCT04825587 clinical trial?

NCT04825587 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Neeraj Patel, MD at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 240 participants.

Related Trials

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology