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?

This trial examines whether adding Anterolateral Ligament (ALL) reconstruction to ACL reconstruction improves long-term outcomes for children with ACL injuries. The goal is to determine if this combination reduces the risk of graft failure compared to ACL surgery alone. The trial seeks children who need their first ACL surgery within six months of injury and have not had previous knee surgeries. This research could improve recovery and reduce future knee problems for young athletes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance recovery strategies for young athletes.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that undergoing both ACL and ALL surgeries together is generally safe. Studies have found that the graft failure rate is less than 3% after at least two years for patients who have both surgeries, indicating that the treatment is usually well-tolerated. Additionally, combining these surgeries may enhance knee stability and reduce the risk of re-injury compared to having only ACL surgery.

Overall, both surgeries are well-researched and have demonstrated good results in past studies, making them relatively safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach of combining ACL and ALL reconstruction for ACL injuries because it addresses both the ACL and the anterolateral ligament (ALL) simultaneously. Unlike standard ACL reconstruction surgery alone, which only repairs the ACL, this dual reconstruction aims to provide better rotational stability of the knee, potentially reducing the risk of re-injury. By targeting both ligaments, the hope is to enhance overall knee function and improve long-term outcomes for patients, offering a more comprehensive solution to knee stability issues.

What evidence suggests that this trial's treatments could be effective for anterior cruciate ligament injury?

This trial will compare ACL reconstruction alone with a combined approach of ACL and anterolateral ligament (ALL) reconstruction. Research has shown that adding ALL reconstruction to ACL surgery can lead to better outcomes. Specifically, studies have found that this combined approach improves muscle performance and reduces fear of movement compared to ACL repair alone. Participants undergoing both ACL and ALL reconstruction may experience fewer instances of new ligament tears and more successful meniscus repairs, which is the knee cartilage. Overall, the combined surgery tends to result in better knee function and stability than repairing the ACL alone. ^{1 4 5 6 7}

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

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 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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759739/

All-inside anterior cruciate ligament reconstruction with and ... Combined reconstruction of the anterolateral ligament in chronic ACL injuries leads to better clinical outcomes than isolated ACL reconstruction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6250270/

Clinical Outcomes After Combined Anterior Cruciate Ligament ... Overall, combined ACL and ALL reconstruction provides promising results that may improve graft rupture rates and meniscal repair failure rates.

3. nature.com nature.com/articles/s41598-024-62444-x

Addition of anterolateral ligament reconstruction to primary ... The addition of ALLR to primary ACLR yielded better muscle performance, fear of movement, and functional performance than isolated ACLR.

4. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00184-1/fulltext

Combined Anterior Cruciate Ligament and Anterolateral ... Combined reconstruction of the anterolateral ligament in chronic ACL injuries leads to better clinical outcomes than isolated ACL reconstruction.

5. kneesurgrelatres.biomedcentral.com kneesurgrelatres.biomedcentral.com/articles/10.1186/s43019-021-00115-1

Clinical outcomes of combined anterior cruciate ligament and ... Combined ACL and ALL reconstruction obtained better postoperative clinical outcomes when compared with isolated ACL reconstruction, especially in reducing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806325002439

Combined Anterolateral and Anterior Cruciate Ligament ... We proved that the combined ACLR+ALLR approach yielded superior residual laxity and pivot-shift test compared to isolated ACLR.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10673961/

Short-term outcomes of anterior cruciate ligament ... This study aimed to compare the short-term outcomes of ACL reconstruction (ACLR) alone, ACLR with lateral tenodesis, and ACL and ALL reconstruction.