Actively Recruiting
The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
Led by Ann & Robert H Lurie Children's Hospital of Chicago ยท Updated on 2026-05-29
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding an anterolateral ligament (ALL) reconstruction to the standard anterior cruciate ligament (ACL) surgery in children can reduce the chances of graft failure over time. The study focuses on pediatric patients who have experienced ACL injuries, a condition that has been increasing among children and adolescents. Since children tend to have higher rates of complications after ACL surgeries compared to adults, this trial aims to provide new evidence on how to improve outcomes and reduce re-injury risks in this vulnerable group. Participants will be randomly assigned to one of two groups: one group will receive both ACL and ALL reconstruction surgery, while the other will have only the ACL reconstruction. Both surgeries involve reconstructing the knee ligaments, with the ALL procedure being investigated for its potential to improve knee stability. The study will follow participants for up to five years to compare the rates of graft failure and other outcomes between the two groups. During the trial, children will be monitored through regular follow-ups to assess graft success, complications, and patient-reported outcomes related to knee function and quality of life. Data collection will continue until all 780 participants have completed their interventions and follow-up period. This long-term observation will help researchers understand the benefits and risks of combining ALL reconstruction with ACL surgery in children and adolescents.
CONDITIONS
Brief Title
The Pediatric ALL Evaluation and Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and days following hospital discharge
Participants will undergo surgery either with both ACL and ALL reconstruction or ACL reconstruction alone, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 5 years
Participants are monitored for recovery, complications, and graft success after surgery.
Regular follow-up visits during recovery and long-term monitoring visits
Trial Site Locations
Total: 1 location
1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Amanda Kass
N
Neeraj Patel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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