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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
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.
Procedure/SurgeryBy 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Concomitant ACL and ALL reconstructionExperimental treatment 1 intervention
Group B: ACL reconstruction aloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Graft failure
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.
Time frame
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.Secondary outcomes
1
Complications of ALL reconstruction
To determine the rate and severity of complications related specifically to ALL reconstruction in children.
Time frame
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.2
Patient reported outcome measures
To collect and compare patient reported outcome (PRO) scores (as measured by the Pedi-IKDC, Lysholm, HSS Pedi-FABS, and PROMIS surveys) in children undergoing ACL reconstruction alone, and children undergoing combined ACL and ALL reconstruction.
Time frame
Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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