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

(PALLET Trial)

Overseen By Amanda Kass

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Over 18, Neuromuscular disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate recovery

240 Participants Needed

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. ^{1 2 3 4 5}

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. ^{4 5 6 7 8}

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. ^{2 4 6 9 10}

Who Is on the Research Team?

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.

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.

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?

Group I: Concomitant ACL and ALL reconstruction Experimental Treatment 1 Intervention

The participant will undergo both the ACL and ALL reconstruction surgery.

Group II: ACL reconstruction alone Experimental Treatment 1 Intervention

The participant will undergo only ACL reconstruction surgery.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A meta-analysis of 1495 patients showed that combined reconstruction of the ACL and anterolateral ligament (ALL) significantly reduces the risk of residual pivot shift and rerupture rates compared to isolated ACL reconstruction.

Patients who underwent combined ACL and ALL reconstruction also had better postoperative outcomes, as indicated by improved Lachman test results and higher Lysholm scores, suggesting enhanced knee stability and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. Ariel de Lima, D., de Lima, LL., de Souza, NGR., et al.[2021]

In a study of 63 patients with ACL injuries, combining anterolateral ligament (ALL) suture tape augmentation with ACL reconstruction resulted in better anteroposterior stability, as measured by KT-1000 arthrometry, compared to isolated ACL reconstruction.

Despite the improved stability, the overall functional outcomes and graft failure rates were not significantly different between the two groups, suggesting that while the combined approach may enhance stability, it does not necessarily lead to better functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the outcomes of isolated anterior cruciate ligament reconstruction and combined anterolateral ligament suture tape augmentation and anterior cruciate ligament reconstruction. Erden, T., Toker, B., Toprak, A., et al.[2021]

In a study of 958 patients undergoing ACL reconstruction, the overall complication rate was 39%, with anterior knee pain, stiffness, and secondary meniscal lesions being the most common issues reported.

The patellar tendon graft showed a significantly lower rerupture rate compared to the hamstring graft (3.1% vs 7%), while complications related to hardware were more frequent in the hamstring group, suggesting that graft choice can impact postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. Rousseau, R., Labruyere, C., Kajetanek, C., et al.[2020]

ACL reconstruction is a generally safe and effective procedure for knee stability, but infections, although rare, can lead to serious complications and poor outcomes.

Early diagnosis and treatment of infections with culture-specific antibiotics and debridement are crucial to prevent further damage to the knee, while the type of graft used does not appear to influence infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. Stucken, C., Garras, DN., Shaner, JL., et al.[2022]

Patients who underwent combined anterior cruciate ligament and anterolateral ligament reconstruction (ACL+ALLR) had significantly better long-term graft survivorship (96.5%) compared to those who had isolated ACL reconstruction (82.6%), indicating a more effective surgical approach.

The study found that patients with isolated ACL reconstruction were over five times more likely to experience graft rupture and require revision surgery compared to those who had the combined procedure, highlighting the benefits of ACL+ALLR in reducing reoperation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sonnery-Cottet, B., Haidar, I., Rayes, J., et al.[2021]

In a study of 107 male athletes with ACL tears, those who underwent combined ACL and anterolateral ligament (ALL) reconstruction showed significantly better outcomes, including reduced knee laxity and improved stability compared to those who had only ACL reconstruction.

The combined procedure resulted in a higher percentage of patients achieving normal International Knee Documentation Committee (IKDC) scores (96% in the combined group vs. 84.6% in the ACLR group), indicating better overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterolateral ligament reconstruction improves the clinical and functional outcomes of anterior cruciate ligament reconstruction in athletes. Hamido, F., Habiba, AA., Marwan, Y., et al.[2021]

In a study of 80 patients with a mean follow-up of 104 months, combined ACL reconstruction (ACLR) and anterolateral ligament reconstruction (ALLR) did not increase the risk of osteoarthritis (OA) compared to isolated ACLR.

Isolated ACLR using bone-patellar tendon-bone (BPTB) grafts was associated with a significantly higher risk of medial patellofemoral joint space narrowing, indicating potential long-term joint issues compared to ACLR + ALLR.

NCBI (Pubmed)

pubmed.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. Shatrov, J., Freychet, B., Hopper, GP., et al.[2023]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Anatomic reconstruction of the anterior cruciate ligament of the knee with or without reconstruction of the anterolateral ligament: A meta-analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction in patients with or without accompanying injuries: A re-examination of subjects 5 to 9 years after reconstruction. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. [2021]

5. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of the outcomes of isolated anterior cruciate ligament reconstruction and combined anterolateral ligament suture tape augmentation and anterior cruciate ligament reconstruction. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. Germany pubmed.ncbi.nlm.nih.gov

Anterolateral ligament reconstruction improves the clinical and functional outcomes of anterior cruciate ligament reconstruction in athletes. [2021]

10. United States pubmed.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]