Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Location status: Recruiting
NCT Number: NCT04825587
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
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 sustain graft rupture. This can have substantial medical, financial, and psychosocial implications on the patient and family. Additionally, the results of revision ACL reconstruction are, on average, worse than after index surgery. Exploration of treatments that may lower the rate of re-injury is paramount in this population that is at highest risk.
In the adult population, a growing number of studies have suggested that concomitant reconstruction of the anterolateral ligament (ALL) with the ACL may help lower this risk. The ALL was likely first characterized in 1879 by the French surgeon Segond, who commented on the presence of a "pearly, resistant, fibrous band" in the lateral aspect of the knee. However, only in 2012 was the structure given the name "anterolateral ligament" after it was consistently identified in cadaveric specimens. Some studies suggest that the ALL is damaged during anterior cruciate ligament (ACL) injury, implying that it may supplement the ACL in providing rotational and translational stability. Biomechanical studies have confirmed that it likely plays a role in rotational stability.
A number of ALL reconstruction techniques have been developed with the hope of lowering the rate of re-injury after ACL reconstruction. Early literature in the adult population suggests that this may indeed be the case. Early case series suggested that concomitant ALL reconstruction resulted in high rates of return to sport and a low ACL graft failure rate (2.6%). Comparative retrospective studies in adults suggest better patient reported outcome scores, meniscal repair healing, and rates of return to sports when the ALL is reconstructed with the ACL compared to isolated ACL reconstruction. Finally, a prospective cohort study of adults reported that hamstring autograft ACL reconstruction with concomitant ALL reconstruction resulted in 3.1 times lower odds of graft failure than isolated hamstring ACL reconstruction and 2.5 times lower odds of failure than isolated patellar tendon ACL reconstruction.
The hypotheses to be tested in this study have never been evaluated in the pediatric population. Furthermore, the proposed investigation is a randomized controlled trial, which will allow it to provide novel results with high-level evidence. The results of such a study have the potential to change practice in a meaningful, tangible way and affect the outcomes of thousands of children annually. In addition to the medical and functional impact, there could also be important financial and psychosocial implications.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Amanda Kass
CONTACT
Neeraj Patel, MD
CONTACT
Ann & Robert H Lurie Children's Hospital of Chicago
Other
The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial
Acronym: PALLET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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