RecruitingNot ApplicableNCT04825587

The Pediatric ALL Evaluation and Trial

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

240 participants

Start Date

Apr 28, 2021

Study Type

INTERVENTIONAL

Conditions

ACL Injury ACL Tear

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

Max Age: 18 Years

Inclusion Criteria5

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 Criteria9

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

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Interventions

PROCEDUREPatients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.

By randomizing patients into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone, following statistical analysis, we hope 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.