240 Participants Needed

ACL and ALL Reconstruction vs ACL Alone for Anterior Cruciate Ligament Injury

(PALLET Trial)

LS
NP
AK
Overseen ByAmanda Kass
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is ACL and ALL reconstruction safe for humans?

ACL and ALL reconstruction is generally considered safe, but like any surgery, it carries some risks. Infections are rare but can lead to serious complications, and the combined procedure may reduce the risk of graft rupture compared to ACL reconstruction alone.12345

How does ACL and ALL reconstruction differ from ACL reconstruction alone for knee injuries?

The combined ACL and ALL reconstruction treatment is unique because it not only repairs the ACL but also the anterolateral ligament (ALL), which can lead to better knee stability, lower risk of graft rupture, and higher chances of returning to sports compared to just repairing the ACL alone.45678

What data supports the effectiveness of the treatment ACL and ALL Reconstruction vs ACL Alone for Anterior Cruciate Ligament Injury?

Research shows that combining ACL and ALL reconstruction can lead to better knee stability and lower rates of graft rupture compared to just ACL reconstruction alone. This means the combined treatment might help the knee function better and reduce the chance of needing another surgery.246910

Who Is on the Research Team?

NP

Neeraj Patel, MD

Principal Investigator

Lurie Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children under 18 who need their first ACL (knee ligament) reconstruction surgery within 6 months of injury, using their own tissue. It's not for those with previous knee injuries/surgeries, neuromuscular disorders affecting the knee, or anyone needing more complex knee procedures.

Inclusion Criteria

I had surgery within 6 months after my injury.
I had ACL reconstruction using my own tissue.
My growth plates have stopped growing.
See 1 more

Exclusion Criteria

My growth plates are open, needing surgery that avoids them.
My cartilage injury needs more than just cleaning out.
I am having or have had ligament reconstruction surgery besides the ALL.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction surgery, with or without concomitant ALL reconstruction

Surgery and immediate recovery
1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, complications, and effectiveness of the surgery

Up to 5 years
Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • ACL Reconstruction
  • ALL Reconstruction
Trial Overview The study compares two surgical methods in kids: one adds an extra ligament reconstruction called ALL to the usual ACL repair, and the other does just the ACL repair. The goal is to see if adding ALL lowers the chance of future graft failures.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Concomitant ACL and ALL reconstructionExperimental Treatment1 Intervention
The participant will undergo both the ACL and ALL reconstruction surgery.
Group II: ACL reconstruction aloneExperimental Treatment1 Intervention
The participant will undergo only ACL reconstruction surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials
275
Recruited
5,182,000+

UCSF Benioff Children's Hospital - San Francisco

Collaborator

Trials
1
Recruited
240+

Texas Children's

Collaborator

Trials
2
Recruited
270+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Published Research Related to This Trial

The meta-analysis of 6 randomized controlled trials involving chronic ACL injury patients found that combined reconstruction of the ACL and anterolateral ligament (ALL) only marginally improves knee stability compared to isolated ACL reconstruction.
Patients who underwent isolated ACL reconstruction had a higher graft rupture rate, suggesting that combining ACL and ALL reconstruction may offer better long-term outcomes in terms of graft stability.
Combined Reconstruction of the Anterior Cruciate Ligament and Anterolateral Ligament Injury Compared to the Isolated Reconstruction of the Anterior Cruciate Ligament: A Meta-Analysis.Bucar, AL., Pires, RNA., Silva, RDC., et al.[2021]
In a meta-analysis of six studies involving 460 patients, combined anterior cruciate ligament and anterolateral ligament reconstruction (ACL+ALLR) resulted in significantly better knee stability and function compared to isolated anterior cruciate ligament reconstruction (ACLR), as indicated by lower KT values and positive rates in Lachman and Pivot-shift tests.
Patients who underwent ACL+ALLR also reported higher knee function scores (IKDC and Lysholm) without an increase in infection or complication rates, suggesting that this combined approach is both effective and safe.
Anatomic reconstruction of the anterior cruciate ligament of the knee with or without reconstruction of the anterolateral ligament: A meta-analysis.Yin, J., Yang, K., Zheng, D., et al.[2021]
In a study of 72 patients re-evaluated 5 to 9 years after ACL reconstruction, both those with isolated ACL tears and those with additional injuries showed similar clinical outcomes, indicating that the presence of accompanying injuries does not significantly affect long-term knee function after surgery.
Despite similar overall results, patients with additional injuries (group B) experienced more subsequent knee surgeries compared to those with isolated ACL tears (group A), suggesting that while initial reconstruction may be successful, additional injuries could lead to further complications.
Anterior cruciate ligament reconstruction in patients with or without accompanying injuries: A re-examination of subjects 5 to 9 years after reconstruction.Järvelä, T., Kannus, P., Järvinen, M.[2019]

Citations

Combined Reconstruction of the Anterior Cruciate Ligament and Anterolateral Ligament Injury Compared to the Isolated Reconstruction of the Anterior Cruciate Ligament: A Meta-Analysis. [2021]
Anatomic reconstruction of the anterior cruciate ligament of the knee with or without reconstruction of the anterolateral ligament: A meta-analysis. [2021]
Anterior cruciate ligament reconstruction in patients with or without accompanying injuries: A re-examination of subjects 5 to 9 years after reconstruction. [2019]
Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. [2021]
Comparison of the outcomes of isolated anterior cruciate ligament reconstruction and combined anterolateral ligament suture tape augmentation and anterior cruciate ligament reconstruction. [2021]
Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. [2020]
Infections in anterior cruciate ligament reconstruction. [2022]
Long-term Graft Rupture Rates After Combined ACL and Anterolateral Ligament Reconstruction Versus Isolated ACL Reconstruction: A Matched-Pair Analysis From the SANTI Study Group. [2021]
Anterolateral ligament reconstruction improves the clinical and functional outcomes of anterior cruciate ligament reconstruction in athletes. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Radiographic Incidence of Knee Osteoarthritis After Isolated ACL Reconstruction Versus Combined ACL and ALL Reconstruction: A Prospective Matched Study From the SANTI Study Group. [2023]
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