The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
Ann & Robert H Lurie Children's Hospital of Chicago
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.
Description
Studies have reported a rising incidence of anterior cruciate ligament (ACL) injuries in children and adolescents. Beck et al reported a 2.3% annual increase between 1994 and 2013. In New York State, the rate of pediatric ACL reconstruction climbed from 17.6/100,000 in 1990 to 50.9/100,000 by 2009. Other reports echo these findings. After ACL reconstruction, children are known to be at a higher risk for complications than adults. For example, while the rate of postoperative graft failure in adults was 3% to 4% in large national registries, as many as 12% to 19% of pediatric patients may sustai…
Eligibility
- Age range
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Yes
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 b…
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.
Location
- Lurie Children's HospitalChicago, Illinois