ACL Reconstruction With/Without LET for ACL Injury

(STABILITY 2 Trial)

Not currently recruiting at 32 trial locations

Overseen By Stacey Wanlin

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Previous ACLR, Multiple ligament injury, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best approach for ACL reconstruction (surgery to repair a torn knee ligament) in young, active individuals, particularly athletes. It compares different tissue grafts—from the patellar tendon or quadriceps tendon—and examines whether adding lateral extra-articular tenodesis (LET) improves stability and reduces re-injury. Eligible participants are young athletes with a confirmed ACL tear who engage in sports involving pivoting or quick direction changes. As an unphased trial, this study allows participants to contribute to innovative research that could improve surgical outcomes for 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.

What prior data suggests that these surgical techniques are safe for ACL reconstruction?

Research has shown that combining lateral extra-articular tenodesis (LET) with anterior cruciate ligament reconstruction (ACLR) generally carries a low risk of side effects. One study linked this combined approach to fewer instances of ligament re-tearing without significantly increasing other complications. The observed side effects were mild and uncommon, indicating the treatment's safety.

LET stabilizes the knee after an ACL injury, helping to prevent further injury. Studies have shown that patients tolerate this approach well, and it may reduce the need for additional surgery. This is encouraging for those considering this treatment to avoid future knee issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ACL injuries because they explore the addition of lateral extra-articular tenodesis (LET) to standard ACL reconstruction techniques. LET could potentially enhance knee stability and reduce the risk of re-injury compared to traditional methods that use either bone patellar tendon bone (BPTB) or quadriceps tendon (QT) grafts alone. By combining LET with these existing grafts, the hope is to improve long-term outcomes and provide a more robust repair for athletes and active individuals. This approach is particularly promising because it aims to address some of the limitations of current surgical options by offering enhanced support to the knee.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare ACL reconstruction (ACLR) with and without lateral extra-articular tenodesis (LET). Research has shown that adding LET to ACLR can reduce the likelihood of needing another ACL surgery. Specifically, studies found that patients who underwent both ACLR and LET experienced fewer repeat injuries than those who only had ACLR. This suggests that LET might enhance knee stability. Importantly, these studies did not find more complications with the inclusion of LET, making it a promising option for improving ACL reconstruction outcomes. ^{3 5 6 7 8}

Who Is on the Research Team?

Dianne M Bryant, PhD

Principal Investigator

Western University, School of Physical Therapy & Department of Surgery

Volker Musahl, MD

Principal Investigator

University of Pittsburgh

Alan Getgood, MD

Principal Investigator

Fowler Kennedy Sport Medicine Clinic, Western University, Department of Surgery

James J Irrgang, PT PhD FAPTA

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for young, active individuals aged 14-25 with a fully mature skeleton and an ACL-deficient knee. They must participate in sports that involve pivoting or have certain knee conditions like a pivot shift of grade 2+ or ligamentous laxity. People can't join if they've had previous ACL surgery, multiple ligament injuries needing surgery, inflammatory joint diseases, are pregnant, or cannot consent.

Inclusion Criteria

My knee lacks a functioning ACL.

Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs)

I play a sport that involves quick turns, have a knee that gives way, or my joints are very flexible.

Exclusion Criteria

I need treatment for a painful joint surface problem, not just cleaning.

My legs are unevenly bent inward more than 3 degrees.

I have had ACL reconstruction surgery on one of my knees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo ACL reconstruction surgery using BPTB or QT autograft with or without LET, followed by initial recovery

6 weeks

1 visit (in-person for surgery)

Rehabilitation

Participants follow a standardized rehabilitation protocol to regain knee function and strength

6-12 months

Regular visits with physical therapist

Follow-up

Participants are monitored for graft stability, function, and adverse events

24 months

Follow-up assessments at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Anterior cruciate ligament reconstruction (ACLR)
• Lateral extra-articular tenodesis (LET)

Trial Overview The STABILITY 2 trial is testing two types of grafts used in ACL reconstruction—patellar tendon and quadriceps tendon—and whether adding lateral extra-articular tenodesis (LET) affects the re-injury rate. It's a randomized study involving over a thousand patients to determine the best surgical approach.

How Is the Trial Designed?

Group I: QT + LET Experimental Treatment 2 Interventions

Patients will undergo ACLR using a quadriceps tendon (QT) autograft with LET.

Group II: BPTB + LET Experimental Treatment 2 Interventions

Patients will undergo anterior cruciate ligament reconstruction (ACLR) using a bone patellar bone tendon (BPTB) autograft with lateral extra-articular tenodesis (LET).

Group III: QT alone Active Control 1 Intervention

Patients will undergo ACLR using a QT autograft without LET.

Group IV: BPTB alone Active Control 1 Intervention

Patients will undergo ACLR using a BPTB autograft without LET.

Anterior cruciate ligament reconstruction (ACLR) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as ACLR for:

• Anterior cruciate ligament rupture
• Knee instability

Approved in United States as ACLR for:

• Anterior cruciate ligament rupture
• Knee instability

Approved in Canada as ACLR for:

• Anterior cruciate ligament rupture
• Knee instability

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

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 4933 patients who underwent anterior cruciate ligament reconstruction (ACLR), the overall complication rate within 30 days post-surgery was low at 1.34%, with the most common issues being symptomatic deep venous thrombosis and infections.

Risk factors for complications included smoking, dyspnea, chronic obstructive pulmonary disease, and recent weight loss, although these factors only explained 3% of the variance in complication rates, suggesting that ACLR is generally safe but requires careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Short-term Complications of Anterior Cruciate Ligament Reconstruction in the United States. Cvetanovich, GL., Chalmers, PN., Verma, NN., et al.[2022]

A systematic review of 26 studies on anterior cruciate ligament reconstruction (ACLR) found that factors such as younger age, female sex, higher BMI, smoking history, and activity levels are associated with poorer patient-reported outcomes two years post-surgery.

High-grade meniscal tears and full-thickness cartilage defects were also linked to worse outcomes, but the evidence was inconsistent, indicating a need for further research to develop a reliable predictive model for ACLR outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limitations in predicting outcome following primary ACL reconstruction with single-bundle hamstring autograft - A systematic review. An, VV., Scholes, C., Mhaskar, VA., et al.[2021]

In a review of approximately 1850 anterior cruciate ligament reconstructions (ACLRs), only 7 cases of post-surgery infection were identified, resulting in an infection rate of 0.37%, indicating that infections are uncommon but can occur.

Most infections were low-severity and successfully treated without complications, although two patients experienced minor residual limitations, highlighting the importance of effective treatment protocols to minimize long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Infection After Anterior Cruciate Ligament Reconstruction. Gobbi, A., Karnatzikos, G., Chaurasia, S., et al.[2018]

The addition of lateral extra-articular tenodesis (LET) or anterolateral ligament reconstruction (ALLR) to revision anterior cruciate ligament reconstruction (ACLR) significantly improves clinical outcomes, including higher International Knee Documentation Committee (IKDC) scores and better rotational stability, based on a meta-analysis of 10 studies involving 793 patients.

Patients undergoing augmented ACLR (aACLR) were less likely to experience failure compared to those receiving isolated revision ACLR (iACLR), with a failure rate reduction indicated by an odds ratio of 0.44, suggesting that this augmentation is particularly beneficial for those with higher-grade knee laxity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Anterolateral Ligament Reconstruction or Lateral Extra-articular Tenodesis for Revision Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Comparative Clinical Studies. Boksh, K., Sheikh, N., Chong, HH., et al.[2023]

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]

The study evaluated the biomechanical properties of 4-stranded grafts prepared in five different configurations using porcine tendons, revealing that unsecured fixation was the weakest, while end-to-end fixation without secondary fixation had the highest strength and stiffness.

End-to-end fixation outperformed side-to-side fixation in terms of ultimate failure load and stiffness, but adding secondary fixation did not significantly enhance the graft's biomechanical properties, suggesting that securing the graft ends is crucial for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Comparison of Graft Preparation Techniques for All-Inside Anterior Cruciate Ligament Reconstruction. Bowes, J., Mohamed, N., Baptiste, JJ., et al.[2022]

In a study of 12,967 anterior cruciate ligament reconstruction (ACLR) procedures over an average follow-up of 5.2 years, the revision rate was found to be 2.6%, while the rate of primary contralateral ACLR was higher at 4.6%.

Younger patients (ages 15-19) had a significantly increased risk of both revision ACLR and contralateral ACLR, and factors such as having the surgery at an academic hospital and using allografts also raised the risk of needing a revision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for recurrent anterior cruciate ligament reconstruction: a population study in Ontario, Canada, with 5-year follow-up. Wasserstein, D., Khoshbin, A., Dwyer, T., et al.[2022]

The use of the peroneus longus tendon (PLT) as a graft for anterior cruciate ligament reconstruction (ACLR) showed favorable recovery outcomes in a patient with an ACL rupture, with improvements in pain, knee stability, and ankle function post-surgery.

Post-operative evaluations using the International Knee Documentation Committee (IKDC) and American Orthopedic Foot and Ankle Score (AOFAS) indicated that PLT grafts provide satisfactory results comparable to other graft options, with minimal donor site morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peroneus longus tendon graft for anterior cruciate ligament reconstruction: A case report and review of literature. Wiradiputra, AE., Febyan, ., Aryana, GNW.[2021]

In a systematic review of seven randomized controlled trials involving ACL reconstruction, bone-patellar tendon-bone (BPTB) grafts showed significantly better outcomes in knee stability and function compared to synthetic grafts, as measured by tests like the Lachman and pivot shift tests.

BPTB grafts also had lower complication rates than synthetic grafts, suggesting they may be a safer and more effective option for ACL reconstruction in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patellar tendon versus artificial grafts in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Fan, D., Ma, J., Zhang, L.[2021]

Over the past three decades, the preferred graft choice for anterior cruciate ligament reconstruction (ACLR) has shifted from bone-patellar tendon-bone (BTB) autograft, which was used in nearly 90% of cases in 1992, to hamstring tendon (HT) autograft, which is now favored in over 50% of surgeries.

Quadriceps tendon (QT) autograft has also gained popularity since 2014, indicating a trend towards more individualized graft selection based on patient needs, with autografts being preferred over allografts for ACLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACL Study Group survey reveals the evolution of anterior cruciate ligament reconstruction graft choice over the past three decades. Arnold, MP., Calcei, JG., Vogel, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239354/

Lateral extra-articular tenodesis and anterior cruciate ... The purpose of the present study was to evaluate the clinical outcomes, complications, and rate of return to preinjury sports level in pediatric patients.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806325001367

Anterior Cruciate Ligament Reconstruction With Lateral ... ACLR/LET is increasingly utilized to treat patients with ACL tears and shows a decreased risk for revision ACLR without an increased risk for complications.

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(25)00136-7/abstract

Anterior Cruciate Ligament Reconstruction With Lateral ... In total, 1,022 patients underwent ACLR/LET, and 64,504 patients underwent ACLR for a diagnosis of ACL injury; following 1:1 propensity matching, 1,022 patients ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40010521/

Anterior Cruciate Ligament Reconstruction With Lateral ... ACLR/LET is increasingly utilized to treat patients with ACL tears and shows a decreased risk for revision ACLR without an increased risk for complications.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949705124000343

Lateral extra-articular procedures in anterior cruciate ... Despite advancement in orthopedics, anterior cruciate ligament reconstruction (ACLR) still has a significant graft failure rate.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40501204/

Comparative outcomes of anterior cruciate ligament ... Lateral extra-articular tenodesis (LET) techniques can control rotational laxity and reduce re-rupture by strengthening the anterolateral knee.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780662/

Long-term Outcomes After Anterior Cruciate Ligament ... This study aimed to compare the failure rate, clinical outcomes, and OA incidence of 3 different ACL reconstruction techniques.

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05880-3

Are there any complications after lateral extra-articular ... The analysed studies show that combining LET with ACLR appears to be a safe procedure associated with infrequent and mild side effects.