ACL Reconstruction With/Without LET for ACL Injury

(STABILITY 2 Trial)

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

1236 Participants Needed

Trial Summary

What is the purpose of this trial?

Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.

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 data supports the effectiveness of the treatment Anterior cruciate ligament reconstruction (ACLR) with or without Lateral extra-articular tenodesis (LET) for ACL injury?

Research shows that ACL reconstruction (ACLR) is highly successful in restoring knee stability and function, allowing patients to return to activities they enjoy. Additionally, Lateral extra-articular tenodesis (LET) has been shown to improve rotational stability and reduce failure rates in ACL surgeries, especially in revision cases. ^{1 2 3 4 5}

Is ACL reconstruction with or without LET generally safe for humans?

ACL reconstruction is generally considered safe, but there is a small risk of infection, which can lead to serious complications if it occurs. ^{1 6 7 8 9}

How is ACL reconstruction with or without LET different from other treatments for ACL injuries?

ACL reconstruction (ACLR) with or without lateral extra-articular tenodesis (LET) is unique because it not only aims to restore knee stability but also addresses rotational stability, which can reduce failure rates, especially in revision surgeries. This approach is different from traditional ACLR, which primarily focuses on restoring the ligament's function without specifically targeting rotational stability. ^{1 4 10 11 12}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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 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]

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]

References

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

Risk Factors for Short-term Complications of Anterior Cruciate Ligament Reconstruction in the United States. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

ACL Study Group survey reveals the evolution of anterior cruciate ligament reconstruction graft choice over the past three decades. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Limitations in predicting outcome following primary ACL reconstruction with single-bundle hamstring autograft - A systematic review. [2021]

4. United States 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. [2023]

5. 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]

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

Infections in anterior cruciate ligament reconstruction. [2022]

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

Risk factors for recurrent anterior cruciate ligament reconstruction: a population study in Ontario, Canada, with 5-year follow-up. [2022]

8. 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]

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

Postoperative Infection After Anterior Cruciate Ligament Reconstruction. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Peroneus longus tendon graft for anterior cruciate ligament reconstruction: A case report and review of literature. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Patellar tendon versus artificial grafts in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. [2021]

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

Biomechanical Comparison of Graft Preparation Techniques for All-Inside Anterior Cruciate Ligament Reconstruction. [2022]