The Pediatric ALL Evaluation and Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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
Qualifiers
Age 18 and under
Surgery within 6 months of injury
Undergoing primary ACL reconstruction without previous injury or surgery
Quadriceps tendon autograft ACL reconstruction
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.
Treatment groups
240 Participants
are divided into 2 treatment groupsLocations
1Lurie Children's Hospital60611, ChicagoIllinois, United States
Sponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Baylor College of Medicine
Collaborator
UCSF Benioff Children's Hospital - San Francisco
Collaborator
Source ClinicalTrials.gov