Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04825587 |
| Other study ID # |
2020-3610 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2021 |
| Est. completion date |
April 1, 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Ann & Robert H Lurie Children's Hospital of Chicago |
| Contact |
Lauren Spirov, MS |
| Phone |
312-227-8427 |
| Email |
lspirov[@]luriechildrens.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
