LET + ACL Reconstruction for Knee Injuries

(STABILITY LTF Trial)

Enrolling by invitation at 7 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Previous ACL reconstruction, Multi-ligament injury, Symptomatic cartilage defect, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a procedure called lateral extra-articular tenodesis (LET) to standard ACL reconstruction affects long-term knee health, particularly the risk of developing osteoarthritis (OA). Researchers aim to determine if combining these treatments benefits or harms knees over time, using imaging and patient feedback. Individuals with a torn ACL who play competitive sports, have specific types of knee instability, or loose ligaments might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future knee treatments.

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?

Studies have shown that adding a lateral extra-articular tenodesis (LET) to anterior cruciate ligament reconstruction (ACLR) is generally safe, with a low rate of complications. Most side effects are rare and mild. In one study, 86% of patients returned to their previous level of sports activity after surgery. Other research found no increase in negative effects when LET was added to ACLR, suggesting that patients tolerate the treatment well. However, some patients might experience knee pain on the side where the surgery was performed. Overall, current data indicate that combining LET and ACLR is a safe option for those considering the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACL + LET treatment because it adds a lateral extra-articular tenodesis (LET) to the traditional ACL reconstruction. This additional step aims to provide extra stability to the knee, potentially reducing the risk of re-injury. Unlike the standard ACL reconstruction alone, this combined approach targets both the ACL and the structures on the outer side of the knee, which may enhance overall joint support. This could be particularly beneficial for athletes or active individuals who place high demands on their knees.

What evidence suggests that this trial's treatments could be effective for knee injuries?

Studies have shown that adding a procedure called lateral extra-articular tenodesis (LET) to anterior cruciate ligament reconstruction (ACLR) increases knee stability. In this trial, one group of participants will receive standard ACL reconstruction, while another group will receive ACL reconstruction with LET. Research indicates that this combination reduces the risk of knee instability by 38% and lowers the chance of ligament repair failure by 67%. These improvements occur because the procedure helps control the knee's twisting movements. Additionally, patients who underwent LET with ACLR reported better movement and function within seven months after surgery. However, there is some concern that LET might increase the long-term risk of developing osteoarthritis, a joint disease. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged up to 25 with an ACL deficient knee, who play competitive pivoting sports and have a significant pivot shift in the knee or general ligament laxity. It's not suitable for those outside of these criteria.

Inclusion Criteria

My knee is unstable when it rotates.

I am between the ages when my bones have stopped growing and 25 years old.

* competitive pivoting sport

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anterior cruciate ligament reconstruction (ACLR) with or without a lateral extraarticular tenodesis (LET)

Not specified

Follow-up

Participants are monitored for the development of osteoarthritis and other outcomes using imaging and patient-reported outcomes over a 10-year period

10 years

What Are the Treatments Tested in This Trial?

Interventions

• ACL Reconstruction
• Lateral Extra-Articular Tenodesis (LET)

Trial Overview The study examines long-term effects of adding Lateral Extra-Articular Tenodesis (LET) to Anterior Cruciate Ligament Reconstruction (ACLR). It aims to determine if LET increases the risk of developing osteoarthritis over a decade.

How Is the Trial Designed?

Group I: ACL + LET Experimental Treatment 2 Interventions

Anatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).

Group II: ACL Reconstruction Active Control 1 Intervention

Standard ACL reconstruction only.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

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

Lateral extra-articular tenodesis and anterior cruciate ... The most important finding of the present study is that the combination of L.E.T. to A.C.L. reconstruction is a safe and effective surgical option in young ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S187705682030164X

ACL reconstruction with lateral extra-articular tenodesis ... Adding lateral extra-articular tenodesis (LET) to the ACL procedure increases the knee's stability by controlling rotational laxity. The aim of this study was ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086805/

Lateral extra‐articular tenodesis improves functional ... The addition of a LET procedure to an ACLR showed important improvements in functional movement outcomes at 7 months post‐operatively with no negative effect ...

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/33696-lateral-extra-articular-tenodesis-and-anterior-cruciate-ligament-reconstruction-in-young-patients-clinical-results-and-return-to-sport

Lateral extra-articular tenodesis and anterior cruciate ... The most important finding of the present study is that the combination of L.E.T. to A.C.L. reconstruction is a safe and effective surgical ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/26350254241302346

Lateral Extra-articular Tenodesis in ACL Reconstruction Performing LET in conjunction with ACL reconstruction decreases postoperative rotational instability and may decrease ACL failure in appropriately selected ...

6. 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.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806325004359

Indications for Lateral Extra-articular Procedures in the ... Heard et al. No increase in adverse events with lateral extra-articular tenodesis augmentation of anterior cruciate ligament reconstruction—results from the ...

8. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00286-5/fulltext

Minimally Invasive Lateral Extra-Articular Tenodesis Using ... Low-profile design prevents implant irritation, Patients may experience prolonged lateral-sided knee pain due to ITB donor-site morbidity ; The ...