Evaluating ACL and ALL Reconstruction in Children
The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
NA · Ann & Robert H Lurie Children's Hospital of Chicago · NCT04825587
This study is testing if kids who have surgery for a knee ligament injury do better when they have two ligaments fixed instead of just one.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04825587 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to assess whether the reconstruction of the anterolateral ligament (ALL) alongside the anterior cruciate ligament (ACL) in children undergoing surgery can reduce the rate of graft failure compared to ACL reconstruction alone. Given the rising incidence of ACL injuries in the pediatric population, this study seeks to address the higher risk of complications and re-injury faced by these young patients. Participants will be randomly assigned to receive either both ACL and ALL reconstruction or ACL reconstruction alone, with the goal of determining the long-term effectiveness of the combined approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 18 and under who are undergoing primary ACL reconstruction within six months of their injury.
Not a fit: Patients over 18 years old or those with previous knee injuries or surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the risk of graft failure in children undergoing ACL reconstruction.
How similar studies have performed: While studies in adults have shown promise in reducing re-injury rates with concomitant ALL reconstruction, this specific approach in children is still being explored and is considered novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Lurie Children's Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Neeraj Patel, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Amanda Kass
- Email: akass@luriechildrens.org
- Phone: 312-227-1267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ACL Injury, ACL Tear